DEVICE: ORAL BOND
STEINER LABORATORIES 510(k) NO: K142130(Traditional)
ATTN: GREGORY G STEINER PHONE NO : 866 3171348
1051 Olsen Street, Building 3611 SE DECISION MADE: 06-JUN-16
Henderson NV 89011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QiF Blood and Fluid Warmer
Quality in Flow Ltd. 510(k) NO: K150404(Traditional)
ATTN: Neta Sherman PHONE NO : 972 54 6600146
3A Bazel St. POB 10159 SE DECISION MADE: 23-JUN-16
Petach Tikva IL 49002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X-VIEW, IMAGEN
EDLEN IMAGING LLC 510(k) NO: K151137(Abbreviated)
ATTN: NICK RADACHI PHONE NO : 480 6598430
16441 NORTH 91ST STREET SUITE 102 SE DECISION MADE: 07-JUN-16
SCOTTSDALE AZ 85260 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABC D-FLEX PROBE
CONMED CORPORATION 510(k) NO: K151229(Traditional)
ATTN: SANDY LECLAIR PHONE NO : 1 315 6243435
525 FRENCH ROAD SE DECISION MADE: 02-JUN-16
UTICA NY 11502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NMI DUAL PORT II
NAVILYST MEDICAL, INC. 510(k) NO: K151239(Traditional)
ATTN: ROBIN FULLER PHONE NO : 508 6587986
26 FOREST STREET SE DECISION MADE: 06-JUN-16
MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Smart Set
TOPSPINS, INC. 510(k) NO: K151250(Abbreviated)
ATTN: FREDERICK PRINCE PHONE NO : 734 6236400
403 RIVERVIEW DR SE DECISION MADE: 07-JUN-16
ANN ARBOR MI 48107-7205 510(k) STATEMENT
DEVICE: Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode
OMNITECH SYSTEMS, INC. 510(k) NO: K151976(Traditional)
ATTN: JON D. BARRETT PHONE NO : 219 5315532 235
450 SOUTH CAMPBELL ST. SUITE #2 SE DECISION MADE: 27-JUN-16
VALPARAISO IN 46385 510(k) STATEMENT
DEVICE: PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH Catheter
C.R. Bard, Inc 510(k) NO: K151985(Traditional)
ATTN: Bryan Stone PHONE NO : 801 5225000 5876
605 North 5600 West SE DECISION MADE: 14-JUN-16
Salt Lake City UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve Material
SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K151986(Traditional)
ATTN: MATTHEW GEE PHONE NO : 914 5242099
511 BENEDICT AVENUE SE DECISION MADE: 29-JUN-16
TARRYTOWN NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DCI Edge Dental Chair with Operative Unit
DCI 510(k) NO: K151987(Traditional)
ATTN: ROBERT BELLINGHAM PHONE NO : 503 5372431
305 N. SPRINGBROOK RD. SE DECISION MADE: 01-JUN-16
NEWBERG OR 97132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lucent Intervertebral Body Fusion Device
Spinal Elements Inc. 510(k) NO: K152011(Traditional)
ATTN: Julie Lamothe PHONE NO : 760 6071816
3115 Melrose Dr., Suite 200 SE DECISION MADE: 09-JUN-16
Carlsbad CA 92010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use)
ALFA SCIENTIFIC DESIGNS, INC. 510(k) NO: K152122(Traditional)
ATTN: MICHAEL CHANG-CHIEN PHONE NO : 858 5133888
13200 GREGG ST. SE DECISION MADE: 24-JUN-16
POWAY CA 92064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RADspeed Pro
SHIMADZU CORPORATION 510(k) NO: K152244(Traditional)
ATTN: Toshio Kadowaki PHONE NO : 81 75823 1305
1 Nishinokyo-Kuwabaracho Nakagyo-kSE DECISION MADE: 20-JUN-16
Kyoto JP 604-8511 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aquarius Stoma Measuring Device
DEGANIA SILICONE LTD 510(k) NO: K152246(Traditional)
ATTN: ZOYA LEE PHONE NO : 97 216 755122
SE DECISION MADE: 21-JUN-16
DEGANIA BET IL 1513000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Endobronchial Tube
HENAN TUOREN MEDICAL DEVICE CO., L510(k) NO: K152251(Traditional)
ATTN: MEIZI ZHANG PHONE NO : 0086 1363 3736073
WEIYUAN INDUSTRIAL ZONE, MENGGANG,SE DECISION MADE: 10-JUN-16
XINXIANG CN 453400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wing Smart FEVI and Peak Flow Meter
Sparo Inc. 510(k) NO: K152276(Traditional)
ATTN: Mona Dean PHONE NO :
911 Washington Ave, #809 SE DECISION MADE: 03-JUN-16
Saint Louis MO 63101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Background Pattern Classification [BPc(TM)]
Natus Medical Incorporated DBA Exc510(k) NO: K152301(Traditional)
ATTN: Sanjay Mehta PHONE NO : 905 2875055
2568 Bristol Circle SE DECISION MADE: 03-JUN-16
Oakville CA L6H5S1 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Unifine Pentips/ Unifine Pentips Plus
OWEN MUMFORD LTD 510(k) NO: K152339(Traditional)
ATTN: Patty Cronan PHONE NO : 011 44 1993812021
BROOK HILL SE DECISION MADE: 24-JUN-16
WOODSTOCK GB OX20 ITU 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover
ST. JUDE MEDICAL 510(k) NO: K152342(Traditional)
ATTN: PARITA MEHTA PHONE NO : 651 7564442
6901 PRESTON ROAD SE DECISION MADE: 09-JUN-16
PLANO TX 75024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Regular and Special Umbilical Cord Clamp and Cutter
NINGBO FEITE MEDICAL DEVICE CO., L510(k) NO: K152350(Traditional)
ATTN: CHARLES SHEN PHONE NO : 086 0574 88216088
TONGPENZHA, ZHONGGONGMIAO STREET, SE DECISION MADE: 28-JUN-16
NINGBO CN 315192 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Gemini Bonded Sterilization Wrap
MEDLINE INDUSTRIES, INC. 510(k) NO: K152458(Traditional)
ATTN: Jennifier Mason PHONE NO : 847 6433652
ONE MEDLINE PLACE SE DECISION MADE: 01-JUN-16
MUNDELEIN IL 60060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Spinal Jaxx Interbody Fusion Device
NEUROPRO SPINAL JAXX, INC. 510(k) NO: K152501(Traditional)
ATTN: BENJAMIN J. REMINGTON PHONE NO : 209 5455111
4707 GREENLEAF CT., STE. C SE DECISION MADE: 29-JUN-16
MODESTO CA 95356 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MTR550 (Tentative) Antimicrobial Silver Wound Gel
MEDICAL TECHNOLOGY RESEARCH INC. 510(k) NO: K152519(Traditional)
ATTN: Bhalchandra M. Karandikar PHONE NO : 503 9026279
2650 PROGRESS WAY SE DECISION MADE: 02-JUN-16
WOODBURN OR 97071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Seal Rite Non-Rebreathing Valve
The Lifeguard Store, Inc. 510(k) NO: K152521(Traditional)
ATTN: Amy Hilten PHONE NO : 309 4515858
2012 W. College Ave. SE DECISION MADE: 03-JUN-16
Normal IL 61761 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Communicator Surgical Facemask with Clear Window
Prestige Ameritech, Ltd 510(k) NO: K152561(Abbreviated)
ATTN: Rex Reese PHONE NO : 817 4272700
7201 Iron Horse Blvd. SE DECISION MADE: 03-JUN-16
North Richland Hills TX 76180 510(k) STATEMENT
DEVICE: Anker II Dental Implant System
Alliance Global Technology Co., Lt510(k) NO: K152576(Traditional)
ATTN: YAYUAN CHANG PHONE NO : 886 76 956688
2F., No.92, Luke 5th Rd. SE DECISION MADE: 02-JUN-16
Kaohsiung TW 82151 510(k) STATEMENT
DEVICE: Resmon PRO FULL
MEDICAL GRAPHICS CORP. 510(k) NO: K152585(Traditional)
ATTN: JIM PURDIE PHONE NO : 651 7663358
350 OAK GROVE PARKWAY SE DECISION MADE: 24-JUN-16
ST. PAUL MN 55127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ProteXsure Safety Capsule System
StarCap Medical LLC ( DBA Prism Me510(k) NO: K152597(Traditional)
ATTN: Les Capella PHONE NO : 754 8021990
9604 Exbury Court SE DECISION MADE: 08-JUN-16
Parkland FL 33076 510(k) STATEMENT
DEVICE: Collagen Dental Wound Dressings
COLLAGEN MATRIX, INC. 510(k) NO: K152600(Traditional)
ATTN: GLORIA ZUCLICH PHONE NO : 201 4051477
15 THORNTON ROAD SE DECISION MADE: 23-JUN-16
OAKLAND NJ 07436 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Jeesung Safety Syringe and Single Use Needles
JEESUNG MEDICAL CO LTD 510(k) NO: K152606(Traditional)
ATTN: Choi Yong Hyun PHONE NO : 82 429 326061
54, MUJINI 1-GIL, DAEDEOK-GU SE DECISION MADE: 28-JUN-16
DAEJEON KR 306-130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls
INOVA DIAGNOSTICS, INC. 510(k) NO: K152635(Traditional)
ATTN: Gabriella Lakos PHONE NO : 858 5869900 1393
9900 OLD GROVE RD. SE DECISION MADE: 01-JUN-16
SAN DIEGO CA 92131-1638 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATOVEN-Reusable Laser Fiber
DIOTECH CO 510(k) NO: K152667(Traditional)
ATTN: LEE KYUNG YONG PHONE NO : 82 51 2926237
301, NAKDONG-DAERO, SAHA-GU SE DECISION MADE: 09-JUN-16
BUSAN KR 604812 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LightLas Multi-Wavelength Medical Laser System
LIGHTMED CORPORATION 510(k) NO: K152688(Traditional)
ATTN: Mollie Li PHONE NO : 886 2 26881726
No. 1-1, Lane 1, Pao-An St., Sec 3SE DECISION MADE: 15-JUN-16
New Taipei City TW 23861 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROPERIMETER MP-3
NIDEK CO., LTD. 510(k) NO: K152729(Traditional)
ATTN: YONEJI MIZUNO PHONE NO : 81 533 678901
34-14 MAEHAMA, HIROISHI-CHO SE DECISION MADE: 06-JUN-16
GAMAGORI JP 443-0038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Kerrison Rongeurs
VITALITEC MEDIZINTECHNIK GMBH 510(k) NO: K152734(Traditional)
ATTN: LYNETTE HOWARD PHONE NO : 49 07424 92206
STEIGAECKER 20 SE DECISION MADE: 18-JUN-16
BALGHEIM (BADEN-WURTTEM BERG) DE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lite Touch
FOCUS MEDICAL LLC 510(k) NO: K152737(Traditional)
ATTN: JOHN B LEE PHONE NO : 203 7308885
23 FRANCIS J. CLARKE CIRCLE SE DECISION MADE: 29-JUN-16
BETHEL CT 06801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIEGO ELITE DRILL
GYRUS ACMI, INC 510(k) NO: K152744(Traditional)
ATTN: DOLAN MILLS PHONE NO : 901 3730236
136 TURNPIKE ROAD SE DECISION MADE: 10-JUN-16
SOUTHBOROUGH MA 01772 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DSG Threaded Drill System
SPINEGUARD, S.A. 510(k) NO: K152747(Traditional)
ATTN: STEPHANE BETTE PHONE NO : 33 1 45184519
10 COURS LOUIS LUMIERE SE DECISION MADE: 10-JUN-16
VINCENNES FR 94300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long
SUMITOMO BAKELITE CO., LTD. 510(k) NO: K152771(Traditional)
ATTN: SHIRO AGEHAMA PHONE NO : 81 3 54624811
5-8, HIGASHI-SHINAGAWA 2- CHOME, SSE DECISION MADE: 17-JUN-16
TOKYO JP 140-0002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A Plus Internal Fixture System
T-PLUS IMPLANT TECH. CO., LTD. 510(k) NO: K152786(Traditional)
ATTN: DANA CHENG PHONE NO : 866 2 22981950
NO.41, WUQUAN 6TH RD., WUGU DIST.,SE DECISION MADE: 07-JUN-16
NEW TAIPEI CITY TW 24889 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Liger Medical HTU-110
LIGER MEDICAL, LLC 510(k) NO: K152843(Traditional)
ATTN: STEVE SMITH PHONE NO : 801 2310954
14062 S RUNNING CREEK WAY SE DECISION MADE: 24-JUN-16
DRAPER UT 84020 510(k) STATEMENT
DEVICE: Helios III
LASEROPTEK CO. LTD. 510(k) NO: K152856(Traditional)
ATTN: HONG CHU PHONE NO : 82 31 7379885 8
204 HYNDAI I-VALLEY 223-12 SANGDAISE DECISION MADE: 02-JUN-16
SUNGNAM-SI KR 462-714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Portable ECG Monitor
CONTEC MEDICAL SYSTEMS CO., LTD 510(k) NO: K152863(Traditional)
ATTN: XUEYONG LI PHONE NO : 86 335 8015489
NO. 112 QINHUANG WEST STREET, ECONSE DECISION MADE: 22-JUN-16
QINHUANGDAO CN 066004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SureFine Pen Needle
SHINA MED CORPORATION 510(k) NO: K152877(Traditional)
ATTN: SUNG-SOON PARK PHONE NO : 82 31 80572125
455-30, BOGAEWONSAM-RO, BOGAE-MYUNSE DECISION MADE: 07-JUN-16
ANSEONG-SI KR 456-871 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DermaTherapy Bed Linens
PRECISION FABRICS GROUP, INC. 510(k) NO: K152884(Traditional)
ATTN: Terry Montgomery PHONE NO : 336 5108009
301 N. ELM ST. SUITE 600 SE DECISION MADE: 20-JUN-16
GREENSBORO NC 27401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Corin Optimized Positioning System (OPS)
CORIN USA 510(k) NO: K152893(Traditional)
ATTN: Kathy Trier PHONE NO : 813 3029604
5670 W. CYPRESS ST. SUITE C SE DECISION MADE: 03-JUN-16
TAMPA FL 33607 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Gun Oil, Pink, Gun Oil H2O, Pink Water
EMPOWERED PRODUCTS, INC. 510(k) NO: K152918(Traditional)
ATTN: MATT CARR PHONE NO : 702 2161321
3367 W. OQUENDO RD. SE DECISION MADE: 02-JUN-16
LAS VEGAS NV 89118 510(k) STATEMENT
DEVICE: EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint Scented
ECO MEDI GLOVE SDN. BHD. 510(k) NO: K152937(Traditional)
ATTN: SURESH KUMAR PHONE NO : 603 602 83033
LOT 23826, JALAN TEMBAGA KUNING, SE DECISION MADE: 23-JUN-16
KUMUNTING PERAK MY 34600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VALIDATE D-Dimer Calibration Verification/Linearity Test Kit
MAINE STANDARDS COMPANY LLC 510(k) NO: K152961(Traditional)
ATTN: JAMES CHAMPLIN PHONE NO : 207 8921300
221 US ROUTE 1 SE DECISION MADE: 03-JUN-16
CUMBERLAND FORESIDE ME 04110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NERBRIDGE
TOYOBO CO., LTD. 510(k) NO: K152967(Traditional)
ATTN: YUTA KAWAKATSU PHONE NO : 81 663 483336
2-8 DOJIMA HAMA 2- CHOME SE DECISION MADE: 22-JUN-16
KITA-KU JP 530-8230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes
BIO PROTECH, INC. 510(k) NO: K152984(Traditional)
ATTN: DANIEL WOO PHONE NO : 82 33 7357720
DONGHWA MEDICAL INSTRUMENT COMPLEXSE DECISION MADE: 03-JUN-16
WONJU-SI KR 220-801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter
STERILMED, INC. 510(k) NO: K153006(Traditional)
ATTN: PATRICIA F KAUFMAN PHONE NO : 763 4883211
5010 Cheshire Parkway N, Suite 2 SE DECISION MADE: 23-JUN-16
Plymouth MN 55446 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CELALUX 3
VOCO GMBH 510(k) NO: K153018(Traditional)
ATTN: M TH. PLAUMANN PHONE NO : 49 4721 719219
Anto-Flettner-Str. 1-3 SE DECISION MADE: 23-JUN-16
Cuxhaven DE 27472 510(k) STATEMENT
DEVICE: Digital Blood Pressure Monitor
SUZHOU SUNSPIRI CO., LTD. 510(k) NO: K153033(Traditional)
ATTN: JING ZHANG PHONE NO : 86 512 68238996
NO. 72, HENGSHAN RD., SUZHOU NEW DSE DECISION MADE: 24-JUN-16
SUZHOU CN 215009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NobelDesign Software
NOBEL BIOCARE AB 510(k) NO: K153036(Traditional)
ATTN: CHARLEMAGNE CHUA PHONE NO : 714 2824800 7830
BOX 5190, SE-402 26, VASTRA HAMNAGSE DECISION MADE: 02-JUN-16
GOTEBORG SE SE-411 17 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hermes Medical Imaging Suite v5.6
HERMES MEDICAL SOLUTIONS, AB 510(k) NO: K153056(Traditional)
ATTN: JOAKIM ARWIDSON PHONE NO : 46 819 0325
SKEPPSBRON 44 SE DECISION MADE: 01-JUN-16
STOCKHOLM SE 11130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FitRite™ Total Hip Arthroplasty System
EXCERA ORTHOPEDICS, INC. 510(k) NO: K153057(Traditional)
ATTN: SCOTT COLERIDGE PHONE NO :
1188 Centre St SE DECISION MADE: 23-JUN-16
Newton MA 02459 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: "silky" II POLYDEK, "cottony" II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEEL
Teleflex Medical, Inc. 510(k) NO: K153076(Traditional)
ATTN: Natalie Hichak PHONE NO : 919 4338049
3015 Carrington Mill Blvd SE DECISION MADE: 16-JUN-16
Morrisville NC 27560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LED Curing Light GT-2000
MONITEX INDUSTRIAL CO., LTD. 510(k) NO: K153078(Traditional)
ATTN: Shu-Lung Wang PHONE NO : 886 2 29993869
6F, 70 SEC. 1 GUANG-FU ROAD SAN-CHSE DECISION MADE: 28-JUN-16
NEW TAIPEI CITY TW 241-58 510(k) STATEMENT
DEVICE: ASAHI Fielder XT-A, ASAHI Fielder XT-R
ASAHI INTECC CO., LTD. 510(k) NO: K153106(Traditional)
ATTN: Yoshihiko Fukui PHONE NO : 81 52 7681211
1703 WAKITA-CHO, MORIYAMA-KU SE DECISION MADE: 21-JUN-16
NAGOYA JP 463-0024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20° Hooded Acetabular Liner
SIGNATURE ORTHOPAEDICS PTY LTD. 510(k) NO: K153131(Traditional)
ATTN: DECLAN BRAZIL PHONE NO : 61 2 94285181
7 SIRIUS ROAD SE DECISION MADE: 03-JUN-16
LANE COVE AU 2066 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Initial LiSi Press
GC AMERICA INC. 510(k) NO: K153136(Traditional)
ATTN: MARK HEISS PHONE NO : 708 5970900
3737 W. 127TH STREET SE DECISION MADE: 30-JUN-16
ALSIP IL 60803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LunulaLaser
ERCHONIA MEDICAL, INC. 510(k) NO: K153164(Traditional)
ATTN: STEVE SHANKS PHONE NO : 214 5442227
2021 COMMERCE DR. SE DECISION MADE: 03-JUN-16
MCKINNEY TX 75069 510(k) STATEMENT
DEVICE: NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit
ASTUTE MEDICAL, INC 510(k) NO: K153165(Special)
ATTN: Karin Hughes PHONE NO : 858 5007044
3550 GENERAL ATOMICS COURT BUILDINSE DECISION MADE: 01-JUN-16
SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Admira Fusion Flow
VOCO GMBH 510(k) NO: K153177(Traditional)
ATTN: MANFRED THOMAS PLAUMANN PHONE NO : 49 4 7217190
ANTON-FLETTNER-STR. 1-3 SE DECISION MADE: 30-JUN-16
CUXHAVEN DE 27472 510(k) STATEMENT
DEVICE: MAIA
CENTERVUE SPA 510(k) NO: K153181(Traditional)
ATTN: ROBERTO GABRIOTTI PHONE NO : 39 049 7396147
VIA SAN MARCO 9H SE DECISION MADE: 08-JUN-16
PADOVA IT 35129 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi Blood Glucose Monitoring System
SD BIOSENSOR 510(k) NO: K153201(Special)
ATTN: Yeon Park PHONE NO : 82 31 3000416
C-4th & 5th, 16, Deogyeong-daero, SE DECISION MADE: 24-JUN-16
Suwon-si KR 443-813 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Masimo Root Monitoring System and Accessories
Masimo Corporation 510(k) NO: K153225(Traditional)
ATTN: Marguerite Thomlinson PHONE NO : 949 2977000
52 Discovery SE DECISION MADE: 21-JUN-16
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MySpine Pedicle Screw Placement Guides - LP
Medacta International SA 510(k) NO: K153273(Traditional)
ATTN: Michael G Loiterman PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 29-JUN-16
Castel San Pietro CH ch 6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PowerGlide Pro Midline Catheter
C.R. BARD, INC. 510(k) NO: K153280(Traditional)
ATTN: CASEY COOMBS PHONE NO : 801 5225869
605 NORTH 5600 WEST SE DECISION MADE: 02-JUN-16
SALT LAKE CITY UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Voyant Open Fusion Device
APPLIED MEDICAL RESOURCES 510(k) NO: K153288(Traditional)
ATTN: JESSICA CHO PHONE NO : 949 7137958
22872 Avenida Empresa SE DECISION MADE: 01-JUN-16
Rancho Santa Margarita CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCATTER CORRECTION FOR CXDI SERIES
CANON, INC 510(k) NO: K153312(Traditional)
ATTN: SHINJI MORI PHONE NO : 81 3 37582111
30-2 SHIMOMARUKO, 3-CHROME, OHTA-KSE DECISION MADE: 28-JUN-16
TOKYO JP 146-8501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Quantib Brain 1
QUANTIB BV 510(k) NO: K153351(Traditional)
ATTN: FLOOR VAN LEEUWEN PHONE NO : 31 10 8411749
WESTBLAAK 106 SE DECISION MADE: 17-JUN-16
ROTTERDAM NL NL-3012 KM 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SANDMAN ELITE
EMBLA SYSTEMS 510(k) NO: K153353(Traditional)
ATTN: SHANE T. SAWALL PHONE NO : 613 2548877 1301
1 HINES ROAD SUITE 202 SE DECISION MADE: 23-JUN-16
KANATA CA K2K 3C7 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADMIRE
SIEMENS MEDICAL SOLUTIONS, INC. 510(k) NO: K153360(Traditional)
ATTN: JOHN URTZ PHONE NO : 610 4486002
40 LIBERTY BOULEVARD MAIL CODE 65-SE DECISION MADE: 29-JUN-16
MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S698 Symbioz flow
SOPRO - ACTEON GROUP 510(k) NO: K153367(Traditional)
ATTN: Philippe BOYER PHONE NO : 011 33 442980101
ZAC ATHELIA IV AVENUE DES GENEVRIESE DECISION MADE: 17-JUN-16
LA CIOTAT FR 13705 510(k) STATEMENT
DEVICE: Repagyn vaginal suppositories
FARMA-DERMA S.R.L. 510(k) NO: K153372(Traditional)
ATTN: MARA CALZOLARI PHONE NO : 39 051 6814181
VIA DEI BERSAGLIERI,10 SE DECISION MADE: 30-JUN-16
SALA BOLOGNESE IT 40010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System
ORTHOCARE 510(k) NO: K153374(Traditional)
ATTN: RAJEEV CHHABRA PHONE NO : 91 11 41424511
3/10 KIRTI NAGAR INDUSTRIAL AREA SE DECISION MADE: 17-JUN-16
NEW DELHI IN 110015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMPROSAFE Blood Collection Set with Pre-attached Holder, IMPROVACUTER Blood Collection Set Pre-attached Holder, IMPROSAFE Blood Collection Set, IMPROVACUTER Blood Collection Set, IMPROSAFE Multi Sample Needle, IMPROSAFE Multi Sample Needle (Flashback), IMPROVACUTER Multi Sample Needle
GUANGZHOU IMPROVE MEDICAL INSTRUME510(k) NO: K153388(Traditional)
ATTN: BANGFU SUN PHONE NO : 86 20 32312660
NO. 102, KAIYUAN AVENUE, SCIENCE CSE DECISION MADE: 07-JUN-16
GUANGZHOU CN 510530 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sophono Bone Conduction Systems (S) Configuration and (M) Configuration
SOPHONO INC. 510(k) NO: K153391(Traditional)
ATTN: Rozanne Paciej PHONE NO : 904 3328233
5744 CENTRAL AVE #100 SE DECISION MADE: 16-JUN-16
BOULDER CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PowerMidline Catheter
C.R. BARD, INC 510(k) NO: K153393(Traditional)
ATTN: Casey Coombs PHONE NO : 801 5225869
605 NORTH 5600 WEST SE DECISION MADE: 28-JUN-16
SALT LAKE CITY UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pall-Aquasafe Water Filter
PALL INTERNATIONAL, SARL 510(k) NO: K153434(Traditional)
ATTN: KAREN D PETERSON-DOYLE PHONE NO : 516 8019267
AVE DE TIVOLI3 SE DECISION MADE: 10-JUN-16
FRIBOURG CH 1700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LATERAL Spine Truss System
4Web, Inc. 510(k) NO: K153436(Traditional)
ATTN: Jessee Hunt PHONE NO : 800 2857090
6170 Research Rd., Suite 219 SE DECISION MADE: 06-JUN-16
Frisco TX 75033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Megapulse III Shortwave Diathermy
Accelerated Care Plus 510(k) NO: K153456(Traditional)
ATTN: Patrick Parker PHONE NO : 800 3501100 1827
4999 Aircenter Circle, Suite 103 SE DECISION MADE: 14-JUN-16
Reno NV 89502 510(k) STATEMENT
DEVICE: Quiver Laparoscopic Extendable
ITL Corporation PTY LTD 510(k) NO: K153472(Traditional)
ATTN: Emily Rossiter PHONE NO : 61 3 87733050
1/63 Wells Road SE DECISION MADE: 23-JUN-16
Chelsea Heights, VIC AU 3196 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Surgical Face Mask
XIANTAO RAYXIN MEDICAL PRODUCTS CO510(k) NO: K153496(Traditional)
ATTN: Liang Zhang PHONE NO : 86 728 2617592
NO. 258 PENGCHANG ROAD, MIDDLE STRSE DECISION MADE: 15-JUN-16
Xiantao CN 433018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AnyPlus® Cervical PEEK Cage System
GS Medical Co., Ltd. 510(k) NO: K153517(Traditional)
ATTN: Milan George PHONE NO :
90, Osongsaengmyeong 4-ro SE DECISION MADE: 24-JUN-16
Osong-eup, Cheongwon-gun KR 363-9510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medipure Oxygen-LC System
PRAXAIR DISTRIBUTION, INCORPORATED510(k) NO: K153518(Special)
ATTN: Michael Skrjanc PHONE NO : 330 9493324
175 EAST PARK DRIVE SE DECISION MADE: 03-JUN-16
TONAWANDA NY 14150 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NobelProcera HT ML Full Contour Zirconia Crown
NOBEL BIOCARE AB 510(k) NO: K153534(Traditional)
ATTN: Charlemagne Chua PHONE NO : 714 2824800 7830
BOX 5190, SE-402 26, VASTRA HAMNAGSE DECISION MADE: 06-JUN-16
GOTEBORG SE SE-411 17 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sol-M Insulin Syringe, Sol-M TB Syringe
SOL-MILLENNIUM MEDICAL, INC. 510(k) NO: K153537(Traditional)
ATTN: Jim Barley PHONE NO : 949 4333058
1735 North Brown Road, Suite 100 SE DECISION MADE: 17-JUN-16
Lawrenceville GA 30043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Portable Slit Lamp
SHANGHAI BOLAN OPTICAL-ELECTRIC CO510(k) NO: K153545(Traditional)
ATTN: Johnny Hu PHONE NO : 86 21 69225166
NO.29, Jiuyuan Road, Qingpu IndustSE DECISION MADE: 22-JUN-16
Shanghai CN 201700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AGE Automatic Upper Arm Blood Pressure Monitor
Ageless Health Industrial Co., Ltd510(k) NO: K153552(Traditional)
ATTN: Victor Wan PHONE NO : 86 769 81158038
3/F, A1 Bldg Dongshen Sima IndustSE DECISION MADE: 01-JUN-16
Dongguan CN 523560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml
LIOFILCHEM S.R.L 510(k) NO: K153569(Traditional)
ATTN: Fabio Brocco PHONE NO : 39 085 8930745
64026 ROSETO DEGLI SE DECISION MADE: 22-JUN-16
ABRUZZI IT 510(k) STATEMENT
DEVICE: LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head, Camera Coupler, Tablet Application
SMITH & NEPHEW 510(k) NO: K153606(Traditional)
ATTN: JANICE HASELTON PHONE NO : 978 7491494
150 MINUTEMAN ROAD SE DECISION MADE: 02-JUN-16
ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROMA Calculation Tool Using Elecsys Assays
ROCHE DIAGNOSTICS 510(k) NO: K153607(Traditional)
ATTN: Angelo Pereira PHONE NO : 317 5213544
9115 HAGUE ROAD SE DECISION MADE: 15-JUN-16
INDIANAPOLIS IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture Cartridges, ETHIBOND Polybutilate Coated Polyester Sterile Synthetic Non-Absorbable Suture Cartridges, PROXISURE Suturing Device
Ethicon, LLC 510(k) NO: K153611(Traditional)
ATTN: Marjorie Medina PHONE NO : 1 908 2182113
475 C Street SE DECISION MADE: 03-JUN-16
Los Frailes Industrial Park, Suite510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Endoform Reconstructive Template
Aroa Biosurgery Limited (Formerly 510(k) NO: K153632(Traditional)
ATTN: Yasmin Rai PHONE NO : 64 9 8693035
2 Kingsford Smith Place, Airport OSE DECISION MADE: 16-JUN-16
Auckland NZ 2022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITA ENAMIC Implant Solutions (IS)
VITA ZAHNFABRIK H. RAUTER GMBH CO.510(k) NO: K153645(Abbreviated)
ATTN: BERND WALKER PHONE NO : 49 776 1562361
Spitelgasse 3 SE DECISION MADE: 30-JUN-16
Bad Sackingen DE D-79713 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set
TELEFLEX INC. 510(k) NO: K153652(Traditional)
ATTN: CHET JONES PHONE NO : 919 4332579
3015 CARRINGTON MILL BLVD SE DECISION MADE: 21-JUN-16
MORRISVILLE NC 27560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MaxO2ME
MAXTEC, LLC 510(k) NO: K153659(Traditional)
ATTN: JERALD WILSON PHONE NO : 1 385 5498070
2305 South 1070 West SE DECISION MADE: 10-JUN-16
Salt Lake City UT 841119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Chocolate XD PTCA Balloon Catheter
TriReme Medical, LLC 510(k) NO: K153682(Traditional)
ATTN: Shiva Ardakani PHONE NO : 925 9311300
7060 Koll Center Parkway, Suite 30SE DECISION MADE: 23-JUN-16
Pleasanton CA 94566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERIZONE Sterilizer
TSO3 INC 510(k) NO: K153689(Traditional)
ATTN: NATHALIE RACETTE PHONE NO : 418 6510003 294
2505, AVENUE DALTON SE DECISION MADE: 30-JUN-16
QUEBEC CA G1P 3S5 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer
INFRARED LABORATORY SYSTEMS, LLC (510(k) NO: K153692(Traditional)
ATTN: JULIE PASCHAL PHONE NO : 317 8961565
17408 TILLER COURT SUITE 1900 SE DECISION MADE: 24-JUN-16
WESTFIELD IN 40674 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M3290B Philips IntelliVue Information Center iX
PHILIPS MEDICAL SYSTEMS 510(k) NO: K153702(Traditional)
ATTN: THERESA POOLE PHONE NO : 978 6597621
3000 MINUTEMAN ROAD SE DECISION MADE: 13-JUN-16
ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Strive
DJO, LLC 510(k) NO: K153704(Abbreviated)
ATTN: Rand Daoud PHONE NO : 760 7343037
1430 DECISION ST. SE DECISION MADE: 03-JUN-16
VISTA CA 92081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Getinge Series Warming Cabinet
GETINGE SOURCING, LLC 510(k) NO: K153713(Traditional)
ATTN: BARB SMITH PHONE NO : 585 2146049
1777 EAST HENRIETTA ROAD SE DECISION MADE: 07-JUN-16
ROCHESTER NY 14623 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LifeStream Management System, LifeStream Management Suite, LifeStream Patient Manager, LifeStream Manager, LifeStream Web Manager, LifeStream
HONEYWELL HOMMED, LLC 510(k) NO: K153719(Traditional)
ATTN: Greg Lillegard PHONE NO : 262 2526062
3400 INTERTECH DR. SUITE 200 SE DECISION MADE: 03-JUN-16
BROOKFIELD WI 53045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control
Abbott Laboratories 510(k) NO: K153730(Traditional)
ATTN: Laura Yelvigi Joglekar PHONE NO : 224 6673503
Dept 09AA, Bldg. AP 8, 100 AbbottSE DECISION MADE: 15-JUN-16
Abbott Park IL 60064-6038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MRI Patient Monitor TeslaDUO
MIPM MAMMENDORFER INSTITUT FUR PHY510(k) NO: K153739(Traditional)
ATTN: HANS SCHWAIGER PHONE NO :
OSKAR-VON-MILLER-STR. 6 SE DECISION MADE: 28-JUN-16
MAMMENDORF DE 82291 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RTHawk, HeartVista Cardiac Package
HeartVista, Inc. 510(k) NO: K153740(Traditional)
ATTN: James J Rogers PHONE NO : 650 8007937
4984 El Camino Real, Suite 102 SE DECISION MADE: 30-JUN-16
Los Altos CA 94022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3 Series Phototherapy Unit
DAAVLIN DISTRIBUTING COMPANY 510(k) NO: K153749(Special)
ATTN: MICHELE THIEL PHONE NO : 419 6366304
205 WEST BEMENT STREET SE DECISION MADE: 30-JUN-16
BRYAN OH 43506 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Contact Lens Case (multiple brand name)
DANYANG CHANXIN GLASSES CASES FACT510(k) NO: K160005(Traditional)
ATTN: LEMON CHEN PHONE NO : 86 511 86903193
HUADIAN CHUANGYE PARK, DANGUI ROADSE DECISION MADE: 07-JUN-16
DANYANG CITY CN 212300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: O-pel Laser and families of probe delivery devices
PRECISE LIGHT SURGICAL 510(k) NO: K160012(Traditional)
ATTN: KEN ARNOLD PHONE NO : 844 6691845
310 W. HAMILTON AVE SUITE 210 SE DECISION MADE: 02-JUN-16
CAMPBELL CA 95008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arrow Quickflash Arterial Catheterization Device
ARROW INTERNATIONAL, INC. (SUBSIDI510(k) NO: K160018(Traditional)
ATTN: TRACY LARISH PHONE NO : 610 3780131
2400 BERNVILLE RD SE DECISION MADE: 13-JUN-16
READING PA 19605 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis
Biomet, Inc. 510(k) NO: K160071(Traditional)
ATTN: Carmen Albany PHONE NO : 574 3713024
56 East Bell Drive SE DECISION MADE: 16-JUN-16
Warsaw IN 46581 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial Wound & Skin Cleanser 8oz, Simple Science Antimicrobial Wound & Skin Cleanser 16oz, Simple Science Antimicrobial Wound & Skin Cleanser 23oz
Simple Science, LLC 510(k) NO: K160095(Traditional)
ATTN: Eoin Croke PHONE NO : 612 3674540
5555 W 78th St STE M SE DECISION MADE: 10-JUN-16
Edina MN 55439 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CEREC SpeedGlaze
Sirona Dental Systems GmbH 510(k) NO: K160099(Traditional)
ATTN: Thomas Diesch PHONE NO : 49 6251 160
Fabrikstrasse 31 SE DECISION MADE: 02-JUN-16
Bensheim DE 64625 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Heat Pain Pro
OMRON HEALTHCARE, INC. 510(k) NO: K160115(Traditional)
ATTN: RENEE Thornborough PHONE NO : 847 2475626
1925 WEST FIELD COURT SE DECISION MADE: 03-JUN-16
LAKE FOREST IL 60045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NobelSpeedy Groovy
NOBEL BIOCARE AB 510(k) NO: K160119(Traditional)
ATTN: Charlemagne Chua PHONE NO : 714 2824800 7830
VASTRA HAMNGATAN 1 SE DECISION MADE: 02-JUN-16
GOTEBORG SE se-411 17 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BloodSTOP iX Battle Matrix
LifeSciencePLUS Inc. 510(k) NO: K160130(Traditional)
ATTN: Audrey Vitale PHONE NO : 650 5658172
2520A Wyandotte St. SE DECISION MADE: 29-JUN-16
Mountain View CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OEC Elite MiniView
GE HANGWEI MEDICAL SYSTEMS CO., LT510(k) NO: K160131(Traditional)
ATTN: LIFENG WANG PHONE NO : 86 105 8068888 70252
NO.1 YONGCHANG NORTH ROAD, BEIJINGSE DECISION MADE: 21-JUN-16
BEIJING CN 100176 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: StatStrip Xpress Blood Glucose Monitoring System
NOVA BIOMEDICAL CORPORATION 510(k) NO: K160156(Traditional)
ATTN: Eliza Wang PHONE NO : 781 6473700 743
200 PROSPECT STREET SE DECISION MADE: 23-JUN-16
WALTHAM MA 02454 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The Life Spine Subtalar Implant System
Life Spine 510(k) NO: K160169(Traditional)
ATTN: Randy Lewis PHONE NO : 847 8846117
13951 S Quality Drive SE DECISION MADE: 23-JUN-16
Huntley IL 60142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lehman Manometry Catheter
Wilson-Cook Medical, Inc. 510(k) NO: K160170(Special)
ATTN: Doris A. Hawks PHONE NO : 336 7440157 6293
4900 Bethania Station Road SE DECISION MADE: 20-JUN-16
Winston-Salem NC 27105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BSD4343 Digital Flat Panel X-ray Detector
BONTECH INC. 510(k) NO: K160204(Traditional)
ATTN: Kwang S. Choi PHONE NO : 82 31 3035254
Youngtong-gu Youngtong-dong 980-3,SE DECISION MADE: 09-JUN-16
Suwon-si KR 443-702 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Gold Anchor
NASLUND MEDICAL AB 510(k) NO: K160209(Traditional)
ATTN: Tomas Naslund PHONE NO : 46 73 2620717
VASSVAGEN 21 SE DECISION MADE: 21-JUN-16
HUDDINGE SE 14139 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: s-Clean Tapered II RBM Implant System
Dentis Co., Ltd. 510(k) NO: K160213(Traditional)
ATTN: Sun Chul Shin PHONE NO : 82 53 5822804
99, Seongseoseo-ro, Dalseo-gu SE DECISION MADE: 21-JUN-16
Daegu KR 42718 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Barrier Sleeves and Covers
DENTSPLY International Inc. 510(k) NO: K160232(Traditional)
ATTN: Helen Lewis PHONE NO : 717 4871332
221 West Philadephia Street, SuiteSE DECISION MADE: 07-JUN-16
York PA 17408 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ViaValve Safety I.V. Catheter
SMITHS MEDICAL ASD, INC. 510(k) NO: K160235(Traditional)
ATTN: BRIAN FARIAS PHONE NO : 603 3523812 2493
201 WEST QUEEN STREET SE DECISION MADE: 30-JUN-16
SOUTHINGTON CT 06489 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Airborne Phototherapy Light
INTERNATIONAL BIOMEDICAL 510(k) NO: K160238(Abbreviated)
ATTN: Amy Pieper PHONE NO : 512 8730033
8206 CROSS PARK DR. SE DECISION MADE: 14-JUN-16
AUSTIN TX 78754 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VARIOunite
Thommen Medical AG 510(k) NO: K160244(Traditional)
ATTN: Daniel Snetivy PHONE NO : 41 61 9659020
Neckarsulmstrasse 28 SE DECISION MADE: 02-JUN-16
Grenchen CH 2540 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Additive Orthopaedics Hammertoe Correction System
Additive Orthopaedics, LLC 510(k) NO: K160264(Traditional)
ATTN: Greg Kowalczyk PHONE NO : 732 8826633
83 Amelia Circle SE DECISION MADE: 01-JUN-16
Little Silver NJ 07739 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Image Navigator by Immuno Concepts
Immuno Concepts, NA, Ltd. 510(k) NO: K160265(Traditional)
ATTN: Eric S. Hoy PHONE NO : 214 4610784
9825 Goethe Road; Suite 350 SE DECISION MADE: 17-JUN-16
Sacramento CA 95827 510(k) STATEMENT
DEVICE: Advanced Medical Imaging Software Suite (KSWVWR)
KEOSYS SAS 510(k) NO: K160334(Traditional)
ATTN: Laurence BOY-MACHEFER PHONE NO : 33 0253 591290
13 Impasse Serge Reggiani SE DECISION MADE: 21-JUN-16
SAINT HERBLAIN FR 44815 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECG CT Gating Device
NEOCOIL, LLC 510(k) NO: K160350(Traditional)
ATTN: MICHAEL LEIGH PHONE NO : 262 3471250
N27 W23910A PAUL RD. SE DECISION MADE: 16-JUN-16
PEWAUKEE WI 53072 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VersaWrap Tendon Protector
Alafair Biosciences Inc 510(k) NO: K160364(Traditional)
ATTN: Ben Walthall PHONE NO : 512 4304967
3925 W. Braker Lane, Floor #3 SE DECISION MADE: 10-JUN-16
Austin TX 78759 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K160370(Traditional)
ATTN: Zeng Zhe PHONE NO : 86 755 81885672
MINDRAY BUILDING, KEJI 12TH RD SOUSE DECISION MADE: 09-JUN-16
SHENZHEN CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Miromatrix Biological Mesh
MIROMATRIX MEDICAL INC. 510(k) NO: K160400(Special)
ATTN: JEFF ROSS PHONE NO : 763 4588801
10399 WEST 70TH ST SE DECISION MADE: 08-JUN-16
Eden Prairie MN 55344 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: dynaMX(TM) Nitinol Compression Screw
MX ORTHOPEDICS CORP. 510(k) NO: K160427(Traditional)
ATTN: HOWARD L. SCHRAYER PHONE NO : 609 9249510
1050 WALTHAM STREET SE DECISION MADE: 03-JUN-16
LEXINGTON MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System
Ascensia Diabetes Care US Inc. 510(k) NO: K160430(Special)
ATTN: Jennifer L. Gregory PHONE NO : 574 2563447
430 South Beiger Street SE DECISION MADE: 24-JUN-16
Mishawaka IN 46544 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Identic and KromaFaze Alginate Dental Impression Materials
KERR CORPORATION 510(k) NO: K160441(Traditional)
ATTN: Mohammad Saad Ansari PHONE NO : 909 9625644
1717 W. COLLINS AVE. SE DECISION MADE: 30-JUN-16
ORANGE CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ...
KCI USA, INC. (KINETIC CONCEPTS, I510(k) NO: K160451(Traditional)
ATTN: MELANIE AVILA PHONE NO : 210 5154059
6203 FARINON DRIVE SE DECISION MADE: 20-JUN-16
SAN ANTONIO TX 78249 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BI IMAGE-X EVOLUTION
RADIOTECNOLOGIA INDUSTRIAL S.A. DE510(k) NO: K160458(Traditional)
ATTN: Marcelo Mojica PHONE NO : 01 800 6810538
CALLE PUEBLA SUR, MANZANA 4 LOTE 5SE DECISION MADE: 20-JUN-16
IXTAPALUCA MX 56535 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Synthetic Vinyl Examination Gloves, Powder-Free, Yellow
INPRO TECHNOLOGY DEVICE FACTORY 510(k) NO: K160468(Traditional)
ATTN: WANG YANMEI PHONE NO : 86 536 2197065
NO. 10-1, XING'AN ROAD EAST, LINQUSE DECISION MADE: 23-JUN-16
WEIFANG CN 262600 510(k) STATEMENT
DEVICE: DSM Biomedical Porcine Pericardium Dental Membrane
Kensey Nash Corporation dba DSM Bi510(k) NO: K160474(Traditional)
ATTN: Brianna Schehr PHONE NO : 484 7132100
735 Pennsylvania Drive SE DECISION MADE: 07-JUN-16
Exton PA 19431 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERIFY VH2O2 Indicator Tape
STERIS CORPORATION 510(k) NO: K160485(Traditional)
ATTN: Anthony Piotrkowski PHONE NO : 440 3927437
5960 HEISLEY ROAD SE DECISION MADE: 01-JUN-16
MENTOR OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reprocessed Inquiry Steerable Diagnostic EP Catheter
Innovative Health, LLC. 510(k) NO: K160496(Traditional)
ATTN: Rafal Chudzik PHONE NO : 480 5256006
1435 North Hayden Road, Suite 100 SE DECISION MADE: 10-JUN-16
Scottsdale AZ 85257 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dentivera Milling Disc
Dental Solutions, LLC 510(k) NO: K160498(Traditional)
ATTN: Kendra Shoulders PHONE NO : 770 7728649
7701 Golden Valley Road P.O.Box 27SE DECISION MADE: 15-JUN-16
Golden Valley MN