510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD October 2016
TOTAL 510(k)s THIS PERIOD 235
TOTAL WITH SUMMARIES 223
TOTAL WITH STATEMENTS 12
DEVICE: EasyMap MAP Catheter
MedFact Engineering GmbH 510(k) NO: K151139(Traditional)
ATTN: Joerg Reinhardt PHONE NO : 49 7621 579820
Hammerstr.3 SE DECISION MADE: 18-OCT-16
Loerrach, Baden-Wurttemberg DE D-510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq Flow
SCHUTZ DENTAL GMBH 510(k) NO: K151399(Traditional)
ATTN: ANTJE MAURER PHONE NO : 49 0 60038140
DIESELSTRASSE 5-6 SE DECISION MADE: 24-OCT-16
ROSBACH DE DE 61191 510(k) STATEMENT
DEVICE: KJ Mini Implant System
KJ MEDITECH CO., LTD. 510(k) NO: K151970(Traditional)
ATTN: GOONG-SAN NAM PHONE NO : 82 62 9725476
959-21 DAECHON-DONG, BUK-GU SE DECISION MADE: 21-OCT-16
GWANG-JU KR 959-21 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Painmaster MCT Patch
NEWMARK, INC. 510(k) NO: K151995(Traditional)
ATTN: Francis Powell PHONE NO :
131 Quarry Road SE DECISION MADE: 05-OCT-16
Cheshire CT 06410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Pressure Transducer
ZHEJIANG HAISHENG MEDICAL DEVICE C510(k) NO: K152472(Traditional)
ATTN: Junbin Hu PHONE NO : 86 575 88158510
305#TANGGONG ROAD, PAOJIANG INDUSTSE DECISION MADE: 31-OCT-16
SHAOXING CN 312071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Xonrid Gel
Helsinn Healthcare SA 510(k) NO: K152533(Traditional)
ATTN: Valentina Tombolini Bossi PHONE NO : 41 919 852121
Via Pain Scairolo 9 SE DECISION MADE: 28-OCT-16
Lugano CH 6912 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FilmArray Respiratory Panel EZ (RP EZ)
BIOFIRE DIAGNOSTICS, LLC 510(k) NO: K152579(Dual Track)
ATTN: KRISTEN J. KANACK PHONE NO : 801 7366354 330
390 WAKARA WAY SE DECISION MADE: 03-OCT-16
SALT LAKE CITY UT 84108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dynarex Xeroform Petrolatum Dressing
DYNAREX CORPORATION 510(k) NO: K152970(Traditional)
ATTN: JAMES HURLMAN PHONE NO : 845 3658200
10 GLENSHAW STREET SE DECISION MADE: 03-OCT-16
ORANGEBURG NY 10962 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: aoni Natural Rubber Latex Condom
Guangzhou Daming United Rubber Pro510(k) NO: K153016(Abbreviated)
ATTN: Yongbing Xie PHONE NO : 86 202268 08888687
NO. 1 Daming Street, Port IndustriSE DECISION MADE: 20-OCT-16
Guangzhou CN 510802 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Caremed patient cable and leadwires
SHENZHEN CAREMED MEDICAL TECHNOLOG510(k) NO: K153188(Traditional)
ATTN: XINLIN XIAO PHONE NO : 86 755 2714369
ZONE B, 3/F, 11 BUILDING, HEBEI INSE DECISION MADE: 24-OCT-16
SHENZHEN CN 518021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ETIII SA Fixture System (O3.2mm)
HIOSSEN INC. 510(k) NO: K153332(Traditional)
ATTN: PATRICK LIM PHONE NO : 888 6780001
85 BEN FAIRLESS DR. SE DECISION MADE: 27-OCT-16
FAIRLESS HILLS PA 19030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IH Implant System
Sewon Medix Inc. 510(k) NO: K153521(Traditional)
ATTN: Bum-keun Park PHONE NO : 82 51 3031713
#29, Sa-sang-ro, 375beon-gil, Sa-sSE DECISION MADE: 14-OCT-16
Busan KR 46946 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RS80A Diagnostic Ultrasound System
SAMSUNG MEDISON CO., LTD. 510(k) NO: K153539(Traditional)
ATTN: Kyeong-Mi Park PHONE NO : 82 2 21941373
42, TEHERAN-RO 108-GIL, GANGNAM-GSE DECISION MADE: 03-OCT-16
SEOUL KR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FTRD System Set
OVESCO ENDOSCOPY AG 510(k) NO: K153550(Traditional)
ATTN: MARC O. SCHURR PHONE NO : 49 7071 98979121
DORFACKERSTRASSE 26 SE DECISION MADE: 12-OCT-16
TUEBINGEN DE 72074 510(k) STATEMENT
DEVICE: FREND Testosterone Test System
NanoEnTek USA Inc. 510(k) NO: K153577(Traditional)
ATTN: Jimmy Chen PHONE NO : 925 2250108
5627 Stoneridge Drive Suite 304 SE DECISION MADE: 14-OCT-16
Pleasanton CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sunmed Haemostatic Valves
SUNNY MEDICAL DEVICE (SHENZHEN) CO510(k) NO: K153685(Traditional)
ATTN: James Qi Zhang PHONE NO : 949 2168838
56 LEHIGH AISLE SE DECISION MADE: 13-OCT-16
IRVINE CA 92612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Volumetric Infusion Controller
DEKA RESEARCH & DEVELOPMENT 510(k) NO: K153760(Traditional)
ATTN: Julie Perkins PHONE NO : 603 6695139
340 COMMERCIAL ST. SE DECISION MADE: 03-OCT-16
MANCHESTER NH 03101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: R:GEN Laser System
Lutronic Corporation 510(k) NO: K153769(Traditional)
ATTN: Jhung Won Vojir PHONE NO : 82 31 9083440
219, Sowon-ro, Deogyang-gu SE DECISION MADE: 05-OCT-16
Goyang-si KR 410-220 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOSOGARD FILTERS
Evoqua Water Technologies, LLC 510(k) NO: K153784(Traditional)
ATTN: Robert Dudek PHONE NO : 978 6147359
10 Technology Drive SE DECISION MADE: 21-OCT-16
Lowell MA 01851 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DMi Dental Implant System
DMi Innovative Medical Technology 510(k) NO: K160060(Traditional)
ATTN: Yaniv Haim Buchacho PHONE NO : 972 3 6225879
84 Sokolov St, SE DECISION MADE: 03-OCT-16
Holon IL 58330 510(k) STATEMENT
DEVICE: AUTION ELEVEN Semi-Automated Urinalysis System
ARKRAY, Inc. 510(k) NO: K160062(Traditional)
ATTN: Tom Speikers (U.S. Agent) PHONE NO : 81 75 6628979
Yousuien-Nai, 59 Gansuin-Cho SE DECISION MADE: 07-OCT-16
Kamigyo-Ku JP 602-0008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rampart D Lumbar Interbody Fusion Device
Spineology Inc. 510(k) NO: K160074(Traditional)
ATTN: Karen Roche PHONE NO : 651 2568500
7800 Third Street North, Suite 600SE DECISION MADE: 18-OCT-16
Saint Paul MN 55128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XCage™ Interbody Fusion System
Ouroboros Medical, Inc. 510(k) NO: K160076(Traditional)
ATTN: John To PHONE NO : 510 9333456
47757 Fremont Blvd SE DECISION MADE: 13-OCT-16
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TENS Electrodes
CATHAY MANAFACTURING CORP. 510(k) NO: K160081(Traditional)
ATTN: Ren Ren PHONE NO : 86 21 57878328
No. 328, Xishe Road, Maogang Town,SE DECISION MADE: 19-OCT-16
Shanghai CN 201607 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Prestige Ameritech Pediatric/Child’s Face mask
Prestige Ameritech 510(k) NO: K160100(Traditional)
ATTN: RODNEY GREGORY PHONE NO : 817 4272700
7201 Iron Horse Blvd. SE DECISION MADE: 07-OCT-16
North Richland Hills TX 76180 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Spetzler Malis Dual Illuminating Bipolar Forceps
SYNERGETICS 510(k) NO: K160103(Traditional)
ATTN: DAN REGAN PHONE NO : 636 7945013
3845 CORPORATE CENTRE DRIVE SE DECISION MADE: 12-OCT-16
O' FALLON MO 63368 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SpiroScout
GANSHORN MEDIZIN ELECTRONIC GMBH 510(k) NO: K160116(Traditional)
ATTN: Stefan Ponto PHONE NO : 49 977 1622240
INDUSTRIESTR 6-8 SE DECISION MADE: 07-OCT-16
Niederlauer DE 97618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CorPath GRX System
Corindus, Inc. 510(k) NO: K160121(Traditional)
ATTN: Michael Douglas PHONE NO : 508 6533335
309 Waverley Oaks Road, Suite 105 SE DECISION MADE: 27-OCT-16
Waltham MA 02454 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: miraDry System
Miramar Labs, Inc. 510(k) NO: K160141(Traditional)
ATTN: Kathy O'Shaughnessy PHONE NO : 408 9408700
2790 Walsh Avenue SE DECISION MADE: 31-OCT-16
Santa Clara CA 95051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ClearVision ExamVue Flat Panel Detector
JPI HEALTHCARE, INC 510(k) NO: K160143(Traditional)
ATTN: JANG WON LEE PHONE NO : 82 31 4913435 100
WOOLIM E-BIZ CENTER #608, 170-5 SE DECISION MADE: 28-OCT-16
KURO 3-DONG, KURO-GU KR 152-769 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: I.B.S. 2.0 Osteosynthesis screw
In2Bones SAS 510(k) NO: K160174(Traditional)
ATTN: Morgane Grenier PHONE NO : 33 472 292626
28 chemin du Petit Bois SE DECISION MADE: 06-OCT-16
ECULLY FR 69130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLORADO THERAPEUTICS XENOGRAFT IMPLANT
Colorado Therapeutics LLC 510(k) NO: K160181(Traditional)
ATTN: WILLIAM JACKSON PHONE NO : 303 4699459
2150 WEST 6TH AVENUE SUITE L SE DECISION MADE: 20-OCT-16
BROOMFIELD CO 80020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EnSite Velocity Surface Electrode Kit
ST. JUDE MEDICAL 510(k) NO: K160186(Traditional)
ATTN: YUMI WACKERFUSS PHONE NO : 651 7562675
ONE ST. JUDE MEDICAL DRIVE SE DECISION MADE: 07-OCT-16
ST.PAUL MN 55117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0
ST. JUDE MEDICAL 510(k) NO: K160187(Traditional)
ATTN: MELISSA FRANK PHONE NO : 651 7562954
ONE ST. JUDE MEDICAL SE DECISION MADE: 21-OCT-16
ST. PAUL MN 55117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Advocate Insulin Pen Needles
Diabetic Supply of Suncoast, Inc. 510(k) NO: K160199(Traditional)
ATTN: Victoria Thuss PHONE NO : 787 2706300
Bo.Espinosa Carr.2km.26.2 SE DECISION MADE: 19-OCT-16
Dorado PR 00646-9532 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADAMANT ZIRCONIA DISC
Adamant Co., Ltd. 510(k) NO: K160203(Traditional)
ATTN: Deborah Lavoie Grayeski PHONE NO : 81 3 39191171
1-16-7 Shinden, Adachi Ku SE DECISION MADE: 19-OCT-16
Tokyo JP 123-8595 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: uVue HSG/SHG Catheter
COOK INCORPORATED 510(k) NO: K160217(Traditional)
ATTN: Kara Kanorr PHONE NO : 812 3392235 104072
750 DANIELS WAY SE DECISION MADE: 06-OCT-16
BLOOMINGTON IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Visco (olifilcon A) soft contact lens
Visco Vision Inc 510(k) NO: K160245(Traditional)
ATTN: Evan Huang PHONE NO : 886 3 3596868
No. 1, Xingye St., Guishan Dist., SE DECISION MADE: 24-OCT-16
Taoyuan TW 33341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SimulCare II(TM)
XANACARE TECHNOLOGIES, LLC 510(k) NO: K160246(Traditional)
ATTN: THOMAS C SIIROLA PHONE NO : 720 5549262
9185 EAST KENYON AVENUE # 270 SE DECISION MADE: 06-OCT-16
DENVER CO 80237-1857 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tempo Temporary Pacing Lead
BIO TRACE MEDICAL, INC. 510(k) NO: K160260(Traditional)
ATTN: Laura N. Dietch PHONE NO : 650 7794742
831 BRANSTEN RD, SUITE L SE DECISION MADE: 25-OCT-16
SAN CARLOS CA 94070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fingertip Pulse Oximeter MD300CG11/MD300CG51
BEIJING CHOICE ELECTRONIC TECHNOLO510(k) NO: K160268(Traditional)
ATTN: LEI CHEN PHONE NO : 86 108 8798300 6020
NO.9 SHUANGYUAN ROAD BADACHU HI-TESE DECISION MADE: 14-OCT-16
BEIJING CN 100041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANYVIEW-500R Fluoroscopic Mobile X-Ray System
ECOTRON CO.,LTD 510(k) NO: K160279(Traditional)
ATTN: Sang Bong Lee PHONE NO : 82 2 20253760
RM 504, HANSHIN IT TOWER II, 47, DSE DECISION MADE: 14-OCT-16
SEOUL KR 153-712 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles
PAJUNK GMBH MEDIZINTECHNOLOGIE 510(k) NO: K160294(Traditional)
ATTN: CHRISTIAN G.H. QUASS PHONE NO : 49 077 049291586
KARL-HALL STR. 1 SE DECISION MADE: 21-OCT-16
GEISINGEN DE 78187 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPROTTE NRFit, Quincke NRFit
PAJUNK GmbH Medizintechnologie 510(k) NO: K160295(Traditional)
ATTN: Christian G. H. Quass PHONE NO : 49 0770 49291586
Karl-Hall-Str. 1 SE DECISION MADE: 27-OCT-16
Geisingen DE 78187 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPROTTE SPECIAL NRFit
PAJUNK GMBH MEDIZINTECHNOLOGIE 510(k) NO: K160296(Traditional)
ATTN: CHRISTIAN G.H. QUASS PHONE NO : 49 077 049291586
KARL-HALL STR. 1 SE DECISION MADE: 27-OCT-16
GEISINGEN DE 78187 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tuohy NRFit
PAJUNK GmbH Medizintechnologie 510(k) NO: K160297(Traditional)
ATTN: Christian G.H. Quass PHONE NO : 49 077 049291586
Karl-Hall-Str. 1 SE DECISION MADE: 28-OCT-16
Geisingen DE 78187 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FRAXIS DUO
ILOODA CO., LTD 510(k) NO: K160312(Traditional)
ATTN: YUN JUNG HA PHONE NO : 82 263 662124
120, JANGAN-RO 458 BEON-GIL JANGANSE DECISION MADE: 28-OCT-16
SUWON-SI KR 100-85816200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Xenco Medical Cervical Interbody System
XENCO MEDICAL, LLC 510(k) NO: K160313(Traditional)
ATTN: GUSTAVO PRADO PHONE NO : 858 2021505
9930 MESA RIM ROAD SE DECISION MADE: 21-OCT-16
SAN DIEGO CA 92121 510(k) STATEMENT
DEVICE: SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer Needles
M.D.L. S.r.l. 510(k) NO: K160316(Traditional)
ATTN: Marcello Dell'Oca PHONE NO : 39 0342 68213
Via Tavani 1/a SE DECISION MADE: 27-OCT-16
Delebio (So) IT 23014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALADDIN HW3.0
VISIA IMAGING S.R.L 510(k) NO: K160327(Traditional)
ATTN: Silvia Fantechi PHONE NO : 39 055 9121635
VIA MARTIRI DELLA LIBERTA 95/E SE DECISION MADE: 05-OCT-16
San Giovanni Valdarno IT 52027 510(k) STATEMENT
DEVICE: MAGEC® Spinal Bracing and Distraction System
NuVasive Specialized Orthopedics, 510(k) NO: K160352(Traditional)
ATTN: LANCE JUSTICE PHONE NO : 949 5446540
101 ENTERPRISE SUITE 100 SE DECISION MADE: 21-OCT-16
ALISO VIEJO CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTIMUS CMF SYSTEM
OSTEONIC Co., Ltd. 510(k) NO: K160363(Special)
ATTN: Jisun Lee PHONE NO : 82 2 69028411
1206ho, 38, Digital-ro 29-gil, GurSE DECISION MADE: 20-OCT-16
Seoul KR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NovaPACS
NOVARAD CORPORATION 510(k) NO: K160371(Traditional)
ATTN: DOUG MERRILL PHONE NO : 801 6421001
752 EAST 1180 SOUTH #200 SE DECISION MADE: 14-OCT-16
AMERICAN FORK UT 84003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tyto Stethoscope
Tyto Care Ltd. 510(k) NO: K160401(Traditional)
ATTN: Yoni Iger PHONE NO : 972 54 9599215
Haomanut 12 SE DECISION MADE: 19-OCT-16
Netanya IL 4205445 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers
NEURAL ANALYTICS, INC. 510(k) NO: K160442(Traditional)
ATTN: JAY YONEMOTO PHONE NO : 310 8191676
2127 SAWTELLE BLVD SE DECISION MADE: 21-OCT-16
LOS ANGELES CA 90025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pleurx Pleural Catheter System
CAREFUSION 510(k) NO: K160450(Traditional)
ATTN: JOY GREIDANUS PHONE NO : 847 3628103
75 NORTH FAIRWAY DRIVE SE DECISION MADE: 31-OCT-16
VERNON HILLS IL 60061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cutera enlighten III Laser System
Cutera, Inc. 510(k) NO: K160488(Traditional)
ATTN: Bradley Renton PHONE NO : 415 6575568
3240 Bayshore Blvd. SE DECISION MADE: 28-OCT-16
Brisbane CA 94005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS® Automation Solutions
Ortho-Clinical Diagnostics, Inc. 510(k) NO: K160495(Traditional)
ATTN: Darlene J Phillips PHONE NO : 585 4534253
100 Indigo Creek Drive MC00881 SE DECISION MADE: 18-OCT-16
Rochester NY 14626 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Link Abutment for CEREC
Osstem Implant Co., Ltd 510(k) NO: K160519(Traditional)
ATTN: Hee Kwon PHONE NO : 82 51 8502575
66-16, Bansong-ro 513beon-gil, HaeSE DECISION MADE: 28-OCT-16
Busan KR 612-070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control
SYSMEX AMERICA, INC. 510(k) NO: K160541(Traditional)
ATTN: Michelle Parker PHONE NO : 224 5439639
577 Aptakisic Road SE DECISION MADE: 21-OCT-16
Lincolnshire IL 60069 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOBLUS™ Ultrasound Diagnostic System
HITACHI MEDICAL CORPORATION 510(k) NO: K160559(Traditional)
ATTN: ANGELA VAN ARSDALE PHONE NO : 203 2695088
10 FAIRFIELD BLVD. SE DECISION MADE: 18-OCT-16
WALLINGFORD CT 06492-7502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs
HARTALEGA SND. BHD. 510(k) NO: K160562(Traditional)
ATTN: KUAN KAM HON PHONE NO : 60 36277 1733
C-G-1, JALAN DATARAN SD1 DATARAN SSE DECISION MADE: 13-OCT-16
BANDAR SRI DAMANSARA MY 52200 510(k) STATEMENT
DEVICE: REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip
VOLCANO CORPORATION 510(k) NO: K160583(Traditional)
ATTN: BRIAN PARK PHONE NO : 858 7204176
3721 VALLEY CENTRE DRIVE SUITE 500SE DECISION MADE: 26-OCT-16
SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENROUTE 0.014" Guidewire
LAKE REGION MEDICAL 510(k) NO: K160643(Traditional)
ATTN: MICHAEL DUNNING PHONE NO : 35 391 385037
PARKMORE W BUSINESS PARK SE DECISION MADE: 18-OCT-16
GALWAY IE G07001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dentiq3D
3D INDUSTRIAL IMAGING CO.,LTD. 510(k) NO: K160666(Traditional)
ATTN: Jin Sa Kim PHONE NO : 82 70 87669192
413 Institute Of Computer TechnoloSE DECISION MADE: 05-OCT-16
Gwanak-gu KR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ReNew V Handpiece Laparoscopic Instruments
MICROLINE SURGICAL, INC. 510(k) NO: K160706(Traditional)
ATTN: ANU GAUR PHONE NO : 978 8671726
50 DUNHAM ROAD, SUITE 1500 SE DECISION MADE: 19-OCT-16
BEVERLY MA 01915 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LumFix Spinal Fixation Sytem
CG BIO CO., LTD. 510(k) NO: K160731(Traditional)
ATTN: YUNA JEONG PHONE NO : 82 317 320840
244, GALMACHI-RO, JUNGWON-GU SE DECISION MADE: 04-OCT-16
SEONGNAM-SI KR 13211 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BracePaste Adhesive
American Orthodontics 510(k) NO: K160782(Traditional)
ATTN: Trang Adams PHONE NO : 920 4575051
3524 Washington Avenue SE DECISION MADE: 14-OCT-16
Sheboygan WI 53081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rockwell Medical CitraPure Acid Concetrate
ROCKWELL MEDICAL 510(k) NO: K160847(Traditional)
ATTN: ROBERT CHIOINI PHONE NO : 248 9609009
30142 WIXOM ROAD SE DECISION MADE: 20-OCT-16
WIXOM MI 48393 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cryotop Vitrification Kit and Cryotop Thawing Kit
KITAZATO BIOPHARMA CO., LTD. 510(k) NO: K160864(Traditional)
ATTN: FUTOSHI INOUE PHONE NO : 81 545 662202
81 NAKIJIMA SE DECISION MADE: 07-OCT-16
FUJI JP 416-0907 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PaX-i3D Green Premium (Model: PCT-90LH)
VATECH CO., LTD 510(k) NO: K160882(Traditional)
ATTN: Daniel Kim PHONE NO : 82 313 799492
13, SAMSUNG 1-RO 2-GIL SE DECISION MADE: 28-OCT-16
HWASEONG-SI KR 18449 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HemosIL D-Dimer HS
INSTRUMENTATION LABORATORY CO. 510(k) NO: K160885(Special)
ATTN: CAROL MARBLE PHONE NO : 781 8614467
180 HARTWELL ROAD SE DECISION MADE: 27-OCT-16
BEDFORD MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATTO Mobility Scooter
Moving Life Ltd 510(k) NO: K160909(Traditional)
ATTN: Nino A. Ransenberg PHONE NO : 972 54 5745678
HaOfe 2 SE DECISION MADE: 04-OCT-16
Kadima IL 6092000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterilization Tray
STERIS CORPORATION 510(k) NO: K160912(Traditional)
ATTN: ANTHONY PIOTRKOWSKI PHONE NO : 440 3927437
5960 HEISLEY ROAD SE DECISION MADE: 07-OCT-16
MENTOR OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Gammex Cut-Resistant Glove Liner
ANSELL HEALTHCARE PRODUCTS LLC 510(k) NO: K160974(Traditional)
ATTN: ROBERT MAHLER PHONE NO : 732 3455400
111 WOOD AVENUE SOUTH SUITE 210 SE DECISION MADE: 28-OCT-16
ISELIN NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pantera Pro
BIOTRONIK, INC 510(k) NO: K160985(Traditional)
ATTN: Jon Brumbaugh PHONE NO : 888 3450374
6024 JEAN ROAD SE DECISION MADE: 07-OCT-16
LAKE OSWEGO OR 97035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HPM-6000
BTL INDUSTRIES, INC. 510(k) NO: K160992(Traditional)
ATTN: JAN ZARSKY PHONE NO : 866 2851656
47 LORING DRIVE SE DECISION MADE: 21-OCT-16
FRAMINGHAM MA 01702 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HICP200 Patient/Monitor Interconnect Cable
InnerSpace Neuro Solutions, Inc. 510(k) NO: K161010(Traditional)
ATTN: Gary G. Frugard PHONE NO : 877 4862473 108
1622 Edinger Ave Suite C SE DECISION MADE: 20-OCT-16
Tustin CA 92780 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Z-Clamp ISP System
Zavation, LLC 510(k) NO: K161016(Traditional)
ATTN: James M Philips PHONE NO : 601 9191119
220 Lakeland Parkway SE DECISION MADE: 19-OCT-16
Flowood MS 39232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PK Morcellator
GYRUS ACMI, INC. 510(k) NO: K161038(Traditional)
ATTN: GRAHAM A.L. BAILLIE PHONE NO : 508 8042738
136 TURNPIKE RD SE DECISION MADE: 07-OCT-16
SOUTHBOROUGH MA 02649 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack
Kuraray Noritake Dental, Inc. 510(k) NO: K161042(Traditional)
ATTN: Michio Takigawa PHONE NO : 81 3 67011706
Ote Center Bldg. 7F, 1-1-3, OtemacSE DECISION MADE: 25-OCT-16
Chiyoda ku JP 100-0004 510(k) STATEMENT
DEVICE: ACTABOND Topical Skin Adhesive
BERGEN MEDICAL PRODUCTS, INC. 510(k) NO: K161050(Traditional)
ATTN: Tom Stephens PHONE NO : 855 8553682 703
16 WING DRIVE SE DECISION MADE: 04-OCT-16
Cedar Knolls NJ 07927 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator
Surgitools Pty Ltd. 510(k) NO: K161065(Traditional)
ATTN: Jai Singh PHONE NO : 61 08 93093222
231 Timberlane Dr. SE DECISION MADE: 27-OCT-16
Woodvale AU 6026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Klassic HD Hip System
Total Joint Othopedics, Inc. 510(k) NO: K161073(Traditional)
ATTN: Chris Weaber PHONE NO : 801 4866070
1567 E. Stratford Avenue SE DECISION MADE: 19-OCT-16
Salt Lake City UT 84106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arrow Epidural Catheter Kit
TELEFLEX MEDICAL, INC. 510(k) NO: K161075(Traditional)
ATTN: ANGELA BOUSE PHONE NO : 919 4334904
3015 CARRINGTON MILL BLVD SE DECISION MADE: 04-OCT-16
MORRISVILLE NC 27560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iSR'obot MRI-US Fusion
BIOBOT SURGICAL PTE LTD 510(k) NO: K161109(Traditional)
ATTN: Lai Chee LIEW PHONE NO : 65 635 11868
2 WOODLANDS SPECTRUM 1, #03-10, WSE DECISION MADE: 06-OCT-16
Singapore SG 738068 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ClearPetra Suction-Evacuation Sheath
WELL LEAD MEDICAL CO., LTD. 510(k) NO: K161110(Traditional)
ATTN: Han Guang Yuan PHONE NO : 86 20 84758878
C-4#Jinhu Industrial Estate, HualoSE DECISION MADE: 12-OCT-16
Guangzhou CN 511434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Navien Intracranial Support Catheter
MICRO THERAPEUTICS, INC. D/B/A EV3510(k) NO: K161152(Traditional)
ATTN: Ingrid Takeuchi PHONE NO : 949 2979774
9775 TOLEDO WAY SE DECISION MADE: 12-OCT-16
IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iNSitu Total Hip System
Theken Companies, LLC 510(k) NO: K161184(Traditional)
ATTN: Dale Davison PHONE NO : 330 7337600
1800 Triplett Blvd. SE DECISION MADE: 14-OCT-16
Akron OH 44306 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLEX Elite 9000 SS-OCT
CARL ZEISS MEDITEC, INC. 510(k) NO: K161194(Traditional)
ATTN: CHRISTINE DUNBAR PHONE NO : 925 5605139
5160 HACIENDA DRIVE SE DECISION MADE: 26-OCT-16
DUBLIN CA 94568 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: e-fix E35/E36
Alber GmbH 510(k) NO: K161241(Traditional)
ATTN: MICHAEL VENT PHONE NO : 49 7432 20060
Vor dem Weissen Stein 21 SE DECISION MADE: 05-OCT-16
Albstadt DE 72461 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W
MEDICO ELECTRODES INTERNATIONAL LT510(k) NO: K161282(Traditional)
ATTN: AMIT SETH PHONE NO : 91 120 3042984
PLOT 142A/AA, 12, 27, 28 & 29, NOISE DECISION MADE: 30-OCT-16
NOIDA IN 201305 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MiniBox +
PULMONE ADVANCED MEDICAL DEVICES, 510(k) NO: K161295(Traditional)
ATTN: Avi Lazar PHONE NO : 972 77 5100938
14 HACHAROSHET ST SE DECISION MADE: 21-OCT-16
Ra’ananna IL 4365707 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pour Acrylic
Dentsply Sirona 510(k) NO: K161330(Traditional)
ATTN: Helen Lewis PHONE NO : 717 4871332
221 West Philadelphia Street SuiteSE DECISION MADE: 06-OCT-16
York PA 17404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NanoBone SBX Putty
ARTOSS GMBH 510(k) NO: K161351(Traditional)
ATTN: Walter Gerike PHONE NO : 49 381 54345701
FRIEDRICH-BARNEWITZ-STR. 3 SE DECISION MADE: 26-OCT-16
ROSTOCK DE 18119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HawkOne Directional Atherectomy System
Medtronic Vascular, Inc. 510(k) NO: K161361(Traditional)
ATTN: Rupali Gupta PHONE NO : 763 3987000
(formerly d.b.a ev3 Inc., CovidienSE DECISION MADE: 14-OCT-16
Plymouth MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reprocessed Orbiter ST Steerable Diagnostic EP Catheter
Innovative Health, LLC. 510(k) NO: K161393(Traditional)
ATTN: Rafal Chudzik PHONE NO : 480 5256006
1435 North Hayden Road, Suite 100 SE DECISION MADE: 26-OCT-16
Scottsdale AZ 85257 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VT·One, VT·One 60days
CARILEX MEDICAL, INC. 510(k) NO: K161410(Traditional)
ATTN: Henry Kao PHONE NO : 886 3 3287882
No. 77, Keji 1st Rd., Guishan DistSE DECISION MADE: 13-OCT-16
Taoyuan City TW 333 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
WRP ASIA PACIFIC SDN. BHD. 510(k) NO: K161422(Traditional)
ATTN: SARALA DEVI JAYARAMAN PHONE NO : 6 03 87061486
LOT 1, JALAN 3, KAW PERUSAHAAN BANSE DECISION MADE: 20-OCT-16
SEPANG MY 43900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NeoSpan Compression Staple Impant w/instruments
IN2BONESUSA, LLC 510(k) NO: K161426(Traditional)
ATTN: JOE CLIFT PHONE NO : 901 2607931
6060 POPLAR AVE, SUITE 380 SE DECISION MADE: 24-OCT-16
MEMPHIS TN 38119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HydroSet XT
ORTHOVITA, INC. 510(k) NO: K161447(Traditional)
ATTN: TINA MORNAK PHONE NO : 610 6401775
45 GREAT VALLEY PARKWAY SE DECISION MADE: 06-OCT-16
MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Footmotion Plating System
NEWCLIP TECHNICS 510(k) NO: K161448(Traditional)
ATTN: Gaelle Lussori PHONE NO : 33 228 213712
PA de la Lande Saint Martin-45 rueSE DECISION MADE: 31-OCT-16
HAUTE-GOULAINE FR 44 115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HammerTech Fixation System
Fusion Orthopedics, LLC 510(k) NO: K161449(Traditional)
ATTN: Adam Cundiff PHONE NO : 800 4036876
4135 S. Power Rd., Suite 110 SE DECISION MADE: 11-OCT-16
Mesa AZ 85212 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep Care
Indiba USA Inc. 510(k) NO: K161458(Traditional)
ATTN: Carles Janer PHONE NO : 650 8139700
1717 Embarcadero Road SE DECISION MADE: 03-OCT-16
Palo Alto CA 94303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MR Syringe Dual Pack for Solaris Injectors
Coeur, Inc. 510(k) NO: K161471(Traditional)
ATTN: Priscilla Clinner PHONE NO : 615 5477923
100 Physicians Way SE DECISION MADE: 06-OCT-16
Lebanon TN 37090 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medline Powder-Free Nitrile Exam Glove Extended Cuff (Tested for Use with Chemotherapy Dr)
MEDLINE, INDUSTRIES, INC. 510(k) NO: K161473(Traditional)
ATTN: Jennifer Mason PHONE NO : 847 6433652
ONE MEDLINE PLACE SE DECISION MADE: 19-OCT-16
MUNDELEIN IL 60060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: R2 Dermal Cooling System
R2 Dermatology 510(k) NO: K161480(Traditional)
ATTN: Kristine Tatsutani PHONE NO : 925 3784400
Bishop Ranch 3 2633 Camino Ramon SE DECISION MADE: 05-OCT-16
San Ramon CA 94583 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ambient HipVac 50 Wand with Integrated Finger Switches
ARTHROCARE CORPORATION 510(k) NO: K161481(Traditional)
ATTN: Ashley M. Johnston PHONE NO : 512 3585762
7000 WEST WILLIAM CANNON DRIVE SE DECISION MADE: 21-OCT-16
AUSTIN TX 78735 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Unger Quad Injector
STRADIS HEALTHCARE 510(k) NO: K161483(Traditional)
ATTN: Joseph Trznadel PHONE NO : 847 5967716
805 MARATHON PKWY SUITE 100 SE DECISION MADE: 31-OCT-16
LAWRENCEVILLE GA 30046 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Turbo-Flo PICC Sets
COOK INCORPORATED 510(k) NO: K161496(Traditional)
ATTN: Steven Lawrie PHONE NO : 812 3353575 104518
750 DANIELS WAY SE DECISION MADE: 07-OCT-16
BLOOMINGTON IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dental Implants and Abutments
Ditron Precision Ltd 510(k) NO: K161497(Traditional)
ATTN: Moshe Orlev PHONE NO : 972 86 711841
Haofe 2 St., P.O Box 5010 SE DECISION MADE: 28-OCT-16
Netanya IL 78150 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELEOS Limb Salvage System
Onkos Surgical, Inc. 510(k) NO: K161520(Traditional)
ATTN: Jan Triani PHONE NO : 973 2645400
77 East Halsey Road SE DECISION MADE: 28-OCT-16
Parsippany NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OTC TENS Device, Model PTS-IV
COUNTER SCIENTIFIC DEVELOPMENT (GZ510(k) NO: K161537(Traditional)
ATTN: WENDY POON PHONE NO : 86 203 8289980
2ND &3RD FLOOR, BLD.6 DAPIAN INDUSSE DECISION MADE: 13-OCT-16
GUANGZHOU CN 510665 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Advanced Breast Template System
VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K161540(Traditional)
ATTN: Peter J. Coronado PHONE NO : 650 6469200
911 HANSEN WAY SE DECISION MADE: 20-OCT-16
PALO ALTO CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: R2P SlenGuide
ASHITAKA FACTORY OF TERUMO CORPORA510(k) NO: K161546(Traditional)
ATTN: PHEBE VARGHESE PHONE NO : 732 4124166
150 MAIMAIGI-CHO SE DECISION MADE: 14-OCT-16
FUJINOMIYA SHIZUOKA JP 418-0015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KARL STORZ NAV1 Electromagnetic Navigation System
KARL STORZ Endoscopy America, Inc.510(k) NO: K161555(Traditional)
ATTN: Leigh Spotten PHONE NO : 424 2188738
2151 E. Grand Ave SE DECISION MADE: 21-OCT-16
El Segundo CA 90245 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fingertip Pulse Oximeter MD300CN310
BEIJING CHOICE ELECTRONIC TECHNOLO510(k) NO: K161560(Traditional)
ATTN: LEI CHEN PHONE NO : 86 108 8798300 6020
NO.9 SHUANGYUAN ROAD, BADACHU HI-TSE DECISION MADE: 05-OCT-16
Beijing CN 100041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws
Howmedica Osteonics Corp. aka Stry510(k) NO: K161569(Traditional)
ATTN: Valerie Giambanco PHONE NO : 201 8316275
325 Corporate Drive SE DECISION MADE: 14-OCT-16
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Esophagus Bougie Set
Varian Medical Systems, Inc. 510(k) NO: K161576(Traditional)
ATTN: Peter J. Coronado PHONE NO : 650 4246320
911 Hansen Way SE DECISION MADE: 02-OCT-16
Palo Alto CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Premier Sealant
PREMIER DENTAL COMPANY PRODUCTS 510(k) NO: K161580(Traditional)
ATTN: VINCENT D'ALESSANDRO PHONE NO : 610 2396000
1710 ROMANO DRIVE SE DECISION MADE: 18-OCT-16
PLYMOUTH MEETING PA 19462 510(k) STATEMENT
DEVICE: ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16
ASAHI INTECC CO.,LTD. 510(k) NO: K161584(Traditional)
ATTN: Yoshihiko Fukui PHONE NO : 81 52 7681211
1703 WAKITA-CHO, MORIYAMA-KU SE DECISION MADE: 06-OCT-16
NAGOYA JP 463-0024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSSTEM Implant System
OSSTEM IMPLANT CO., LTD. 510(k) NO: K161604(Traditional)
ATTN: Hee Kwon PHONE NO : 82 51 8502575
66-16, BANSONG-RO 513BEON-GIL, HAESE DECISION MADE: 17-OCT-16
Busan KR 612-070 510(k) STATEMENT
DEVICE: Smart External Drain (SED) System
AQUEDUCT CRITICAL CARE, INC. 510(k) NO: K161605(Traditional)
ATTN: Thomas Clement PHONE NO : 425 9851571
11822 NORTH CREEK PARKWAY NORTH SSE DECISION MADE: 27-OCT-16
Bothell WA 98011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAVUX™ Cervical Cage
PROVIDENCE MEDICAL TECHNOLOGY, INC510(k) NO: K161642(Traditional)
ATTN: Margaret Wong PHONE NO : 415 9239376
1331 N. CALIFORNIA BLVD., SUITE 32SE DECISION MADE: 07-OCT-16
WALNUT CREEK CA 94596 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QuantumCam
DDD-DIAGNOSTIC A/S 510(k) NO: K161674(Abbreviated)
ATTN: Niels Sorensen PHONE NO : 45 45 768888
DR. NEERGAARDS VEJ 5E SE DECISION MADE: 20-OCT-16
HORSHOLM DK 2970 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Q13 SPIROLYSER®
FIM MEDICAL 510(k) NO: K161676(Traditional)
ATTN: LIZA PERRAT PHONE NO : 33 047 2348989
51 RUE PRIMAT CS 60194 SE DECISION MADE: 20-OCT-16
Villeurbanne Cedex , Rhone FR 696510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Straumann Sterile Healing Solution
Institut Straumann AG 510(k) NO: K161677(Traditional)
ATTN: Christopher Klaczyk PHONE NO : 41 61 9651260
Peter Merian Weg 12 SE DECISION MADE: 07-OCT-16
Basel CH CH-4002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Quantum LB
Reliance Orthodontic Products Inc.510(k) NO: K161684(Traditional)
ATTN: Paula Wendland PHONE NO : 630 7734009
1540 West Thorndale Ave SE DECISION MADE: 06-OCT-16
Itasca IL 60143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: D-10 Hemoglobin A1c Program
BIO-RAD LABORATORIES, INC. 510(k) NO: K161687(Traditional)
ATTN: JACKIE BUCKLEY PHONE NO : 510 7415309
4000 ALFRED NOBEL DR. SE DECISION MADE: 14-OCT-16
HERCULES CA 94547 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Acclarent NavWire Sinus Navigation Guidewire
ACCLARENT, INC. 510(k) NO: K161697(Traditional)
ATTN: ANNA HWANG PHONE NO : 949 7898505
33 TECHNOLOGY DRIVE SE DECISION MADE: 24-OCT-16
IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Relieva UltirraNav Sinus Balloon Catheter
ACCLARENT, INC. 510(k) NO: K161698(Traditional)
ATTN: JAMES PATRICK GARVEY PHONE NO : 949 7898505
33 TECHNOLOGY DRIVE SE DECISION MADE: 24-OCT-16
IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARTO ENT System
BIOSENSE WEBSTER 510(k) NO: K161701(Traditional)
ATTN: MELISSA C. SCHULTZ PHONE NO : 909 8398500
3333 DIAMOND CANYON ROAD SE DECISION MADE: 24-OCT-16
DIAMOND BAR CA 91765 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
IMMUNALYSIS CORPORATION 510(k) NO: K161714(Traditional)
ATTN: JOSEPH GINETE PHONE NO : 909 4820840
829 TOWNE CENTER DRIVE SE DECISION MADE: 14-OCT-16
POMONA CA 91767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MaxBlend 2, MaxBlend Lite
Maxtec, LLC 510(k) NO: K161718(Traditional)
ATTN: Bruce Brierley PHONE NO : 385 5498070
2305 South 1070 West SE DECISION MADE: 27-OCT-16
Salt Lake City UT 84119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Standard Clamp
STANDARD BARIATRICS 510(k) NO: K161720(Traditional)
ATTN: Alison Sathe PHONE NO : 513 3047971
4362 GLENDALE MILFORD RD. SE DECISION MADE: 24-OCT-16
CINCINNATI OH 45242 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retail
MEDELA, INC 510(k) NO: K161725(Traditional)
ATTN: ROBERT SOKOLOWSKI PHONE NO : 815 5782220
1101 CORPORATE DRIVE SE DECISION MADE: 28-OCT-16
MCHENRY IL 60050 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Eyenez Ophthalmic Camera
EYENEZ LLC 510(k) NO: K161727(Traditional)
ATTN: DR. KISLINGER PHONE NO : 626 3350535
2619 E.COLORADO BLVD SE DECISION MADE: 04-OCT-16
PASADENA CA 91107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CapsoCam Plus (SV-3) Capsule Endoscope System
CapsoVision, Inc 510(k) NO: K161773(Traditional)
ATTN: Azimun Jamal PHONE NO : 408 6241488
18805 Cox Ave., Suite 250 SE DECISION MADE: 21-OCT-16
Saratoga CA 95070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ClearLumen II Thrombectomy System
Walk Vascular, LLC 510(k) NO: K161786(Traditional)
ATTN: David Look PHONE NO : 949 7529642
17171 Daimler Street SE DECISION MADE: 18-OCT-16
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Avance Tubing, Avance Y-Connector, Avance ViewPad
MOLNLYCKE HEALTH CARE, US LLC 510(k) NO: K161797(Traditional)
ATTN: MEGAN BEVILL PHONE NO : 470 3750049
5550 PEACHTREE PARKWAY SUITE 500 SE DECISION MADE: 19-OCT-16
NORCROSS GA 30092 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band
Genesee BioMedical, Inc. 510(k) NO: K161815(Traditional)
ATTN: Woodrow G. Mathison PHONE NO : 303 7773000
700 W. Mississippi Ave Unit D-5 SE DECISION MADE: 12-OCT-16
Denver CO 80223-4509 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Torcon NB Advantage Catheters
Cook Incorporated 510(k) NO: K161822(Special)
ATTN: Jennifer Allman PHONE NO : 812 3353575 104280
750 Daniels Way SE DECISION MADE: 27-OCT-16
Bloomington IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: kneeEOS
ONEFIT Medical 510(k) NO: K161828(Traditional)
ATTN: Julien Simon PHONE NO : 33 381 252427
18 Rue Alain Savary SE DECISION MADE: 03-OCT-16
Besancon FR 25000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zimmer M/L Taper Hip Prosthesis
ZIMMER, INC. 510(k) NO: K161830(Special)
ATTN: RHONDA MYER PHONE NO : 574 3719659
P.O. BOX 708 SE DECISION MADE: 26-OCT-16
Warsaw IN 46581 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Overwatch Spine System
Amendia, Inc. 510(k) NO: K161842(Traditional)
ATTN: Bruce Hooper PHONE NO : 877 7553329
1755 West Oak Parkway SE DECISION MADE: 13-OCT-16
Marietta GA 30062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Automatic Arm Bluetooth Blood Pressure Monitor
TRULY INSTRUMENT LIMITED 510(k) NO: K161846(Abbreviated)
ATTN: YANG JIAN-HO PHONE NO : 86 0660 3380070
SITE 2, TRULY INDUSTRY AREA SE DECISION MADE: 24-OCT-16
SHANWEI CN 516600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Glass Ionomer Cement (Luting)
SHANDONG HUGE DENTAL MATERIAL CORP510(k) NO: K161851(Traditional)
ATTN: STEVEN SONG PHONE NO : 086 633 2277285
No. 68 Shanhai Road, Donggang DistSE DECISION MADE: 31-OCT-16
Rizhao City CN 276800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS
THE BINDING SITE GROUP LTD 510(k) NO: K161854(Traditional)
ATTN: ANDREA THOMAS PHONE NO : 44 012 14569500
8 CALTHORPE ROAD SE DECISION MADE: 04-OCT-16
EDGBASTON GB B15 1QT 510(k) STATEMENT
DEVICE: PreXion3D Excelsior
PreXion Corporation 510(k) NO: K161881(Traditional)
ATTN: Shumpeita Torii PHONE NO : 81 3 52977551
Funai Tokyo Technology Center BuilSE DECISION MADE: 03-OCT-16
Chiyoda-ku JP 101-0041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CUSA Clarity Ultrasonic Surgical Aspirator System
INTEGRA LIFESCIENCES CORPORATION 510(k) NO: K161882(Traditional)
ATTN: RESHAM RAMSAY PHONE NO : 609 9365529
311 ENTERPRISE DRIVE SE DECISION MADE: 14-OCT-16
PLAINSBORO NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The Cellfina System
ULTHERA, INC. 510(k) NO: K161885(Traditional)
ATTN: SUZON LOMMEL PHONE NO : 480 6454979
1840 S Stapley Drive, Suite 200 SE DECISION MADE: 05-OCT-16
Mesa AZ 85204 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Transtek Blood Pressure Mon