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Medical Devices

June 2015 510(K) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD June 2015
 
 
DEVICE: MEDIKRO SPIROSTAR, M929 Medikro Spirostar USB and M921 Medikro SpiroStar DX
MEDIKRO OY                        510(k) NO: K120577(Traditional)
ATTN: MIKKO  ELORANTA             PHONE NO : 358 172 833000 
KELLOLAHDENTIE 27                 SE DECISION MADE: 24-JUN-15
KUOPIO  FI FI-70460               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: VIDAS FT4
BIOMERIEUX SA                     510(k) NO: K132058(Traditional)
ATTN: AURELIE  PERMEZEL           PHONE NO : 33 478 877483 
5 RUE DES AQUEDUCS                SE DECISION MADE: 08-JUN-15
CRAPONNE  FR 69290                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: SURGICAL FACE MASK (Ear Loops and Tie-on)
B.H. MEDICAL PRODUCTS CO., LTD.   510(k) NO: K133070(Traditional)
ATTN: LEON  LU                    PHONE NO : 877 202-1588 
3500 SOUTH DUPONT HIGHWAY         SE DECISION MADE: 22-JUN-15
DOVER DE  19901                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Plus Surgical Gowns (EO Sterilized), PMGB-XXX
FOSHAN NANHAI PLUS MEDICAL CO., LT510(k) NO: K133075(Traditional)
ATTN: LEON  LU                    PHONE NO : 877 202-1588 
3500 SOUTH DUPONT HIGHWAY         SE DECISION MADE: 24-JUN-15
DOVER DE  19901                   510(k) STATEMENT
                                                    
 
DEVICE: Plus Surgical Drapes (EO Sterilized), PMDB-XXX
FOSHAN NANHAI PLUS MEDICAL CO., LT510(k) NO: K133080(Traditional)
ATTN: LEON  LU                    PHONE NO : 877 202-1588 
3500 SOUTH DUPONT HIGHWAY         SE DECISION MADE: 24-JUN-15
DOVER DE  19901                   510(k) STATEMENT
                                                    
 
DEVICE: MEDIHONEY WOUND DRESSINGS
DERMA SCIENCES, INC.              510(k) NO: K133279(Traditional)
ATTN: SHARMINI  ATHERAY           PHONE NO : 416 299 4003 
104 SHORTING ROAD                 SE DECISION MADE: 25-JUN-15
TORONTO, ONTARIO  CA M1S 3S4      510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: NEURON-SPECTRUM-4/P WITH NEURON-SPECTRUM.NET SOFTWARE
NEUROSOFT LTD                     510(k) NO: K133995(Traditional)
ATTN: ENRICO  BISSON              PHONE NO : 39 049 8630080 
VIA MARZIA N. 9                   SE DECISION MADE: 19-JUN-15
ABANO TERME, PADOVA  IT 35031     510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: TI-OSS
CHIYEWON                          510(k) NO: K140021(Traditional)
ATTN: DANIEL  NAM                 PHONE NO : 213 626-1544 
4568 W. 1ST ST. STE 104           SE DECISION MADE: 05-JUN-15
LOS ANGELES CA  90004             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)
SIEMENS HEALTHCARE DIAGNOSTICS    510(k) NO: K140790(Traditional)
ATTN: HELEN M LEE                 PHONE NO : 302 290-2304 
500 GBC DRIVE M/S 514             SE DECISION MADE: 15-JUN-15
NEWARK DE  19714                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: XENOMEM WOUND MATRIX
VISCUS BIOLOGICS LLC              510(k) NO: K140820(Traditional)
ATTN: ELAINE  DUNCAN              PHONE NO : 715 549-6035 
P.O.BOX 560                       SE DECISION MADE: 26-JUN-15
STILLWATER MN  55082              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ZIBONE ZIRCONIA BLOCKS
COHO TECHNOLOGY CO., LTD          510(k) NO: K140836(Traditional)
ATTN: JACKY  HSEIH                PHONE NO : 03 311220 3 
21 DAFENG ST. LUJU TOWNSHIP       SE DECISION MADE: 17-JUN-15
TAOYUAN COUNTY  TW 33860          510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix
ACELL, INC                        510(k) NO: K141084(Traditional)
ATTN: Salman  Elmi                PHONE NO : 410 9538500 
6640 ELI WHITNEY DR SUITE 200     SE DECISION MADE: 17-JUN-15
COLUMBIA MD  21046                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: CRYOCARE CS SURGICAL SYSTEM
HEALTHTRONICS                     510(k) NO: K141110(Traditional)
ATTN: MARITZA  WARD               PHONE NO : 512 439-8361 
9825 SPECTRUM DR, BLDG 3          SE DECISION MADE: 25-JUN-15
AUSTIN TX  78717-4930             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: MICRODENT GENIUS IMPLANT SYSTEM
IMPLANT MICRODENT                 510(k) NO: K141188(Traditional)
ATTN: RHONDA  ALEXANDER           PHONE NO : 757 224-0177 
144 RESEARCH DRIVE                SE DECISION MADE: 02-JUN-15
HAMPTON VA  23666                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Rightest Blood Glucose Monitoring System GM700, Rightest Blood Glucose Monitoring System GM650, GE200 Blood Glucose Monitoring System, and GE300 Talking Blood Glucose Monitoring System
BIONIME COPORATION                510(k) NO: K141292(Traditional)
ATTN: Feng-Yu  Lee                PHONE NO : 949 218-0929 
29222 RANCHO VIEJO ROAD, SUITE 218SE DECISION MADE: 09-JUN-15
SAN JUN CAPISTRANO CA  92675      510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Captiva Spine SmartLOX Cervical Plate System
CAPTIVA SPINE                     510(k) NO: K141332(Traditional)
ATTN: TAMALA J WAMPLER            PHONE NO : 877 772-5571 
967 ALTERNATE A1A #1              SE DECISION MADE: 11-JUN-15
JUPITER FL  33477                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: VISCO SOFT CONTACT LENS
VISCO VISION INC.                 510(k) NO: K141348(Traditional)
ATTN: JENNIFER  TING              PHONE NO : 886 2 82823192 
6F NO 39, LN 224, JIXIAN RD       SE DECISION MADE: 22-JUN-15
NEW TAIPEI, LUZHOU DIST  TW 247   510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: POWER-TRIALYSIS SLIM-CATH SHORT-TERM DIALYSIS CATHETER
C.R. BARD, INC.                   510(k) NO: K141531(Traditional)
ATTN: BRYAN U STONE               PHONE NO : 801 5225472 
605 NORTH 5600 WEST               SE DECISION MADE: 01-JUN-15
SALT LAKE CITY UT  84116          510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: SPB SKIN EMULSION
BIOTD, S.A.                       510(k) NO: K141637(Traditional)
ATTN: RICHARD  GILLIS, PH.D.      PHONE NO : 512 327-9997 
816 CONGRESS AVENUE - STE 1400    SE DECISION MADE: 03-JUN-15
AUSTIN TX  78701                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN brand of Locking Plates and Locking Screws
AUXEIN MEDICAL                    510(k) NO: K141680(Traditional)
ATTN: RAHUL  LUTHRA               PHONE NO : 91 11 27606663 
103, FIRST FLOOR JYOTI BHAWAN COMMSE DECISION MADE: 30-JUN-15
NEW DELHI  IN 110009              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: BELIMED STEAM STERILIZER MST-H
SAUTER AG                         510(k) NO: K141879(Abbreviated)
ATTN: MICHAEL  HARI               PHONE NO : 41 71 6848500 
ZELGSTRASSE 8                     SE DECISION MADE: 17-JUN-15
SULGEN TG  CH CH-8583             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: VEINOPLUS SPORT NEUROMUSCULAR STIMULATOR
AD REM TECHNOLOGY SARL            510(k) NO: K141919(Traditional)
ATTN: NORMAN F ESTRIN             PHONE NO : 301 279-2899 
9109 COPENHAVER DRIVE             SE DECISION MADE: 16-JUN-15
POTOMAC MD  20854                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: FILAO NC RX PTCA DILATATION CATHETER
NATEC MEDICAL LTD                 510(k) NO: K141933(Traditional)
ATTN: JUDITH  DANIELSON           PHONE NO : 360 904-6512 
5523 RESEARCH PARK DRIVE, SUITE 20SE DECISION MADE: 28-JUN-15
BALTIMORE MD  21228               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: BREATHE TECHNOLOGIES LIFE2000 VENTILATION SYSTEM
BREATHE TECHNOLOGIES              510(k) NO: K141943(Traditional)
ATTN: Samir  Ahmad                PHONE NO : 
175 TECHNOLOGY DR, SUITE 100      SE DECISION MADE: 12-JUN-15
IRVINE CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: DISPOSABLE PRE-GELLED SURFACE ELECTRODE
ROCHESTER ELECTRO MEDICAL, INC.   510(k) NO: K142159(Traditional)
ATTN: WAYNE  GLOVER               PHONE NO : 813 920-4795 
19404 PINE VALLEY DRIVE           SE DECISION MADE: 03-JUN-15
ODESSA FL  33556                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Reliance Cervical IBF System
Reliance Medical Systems, LLC     510(k) NO: K142269(Traditional)
ATTN: Bret M Berry                PHONE NO : 801 2953280 
545 West 500 South, Suite 100     SE DECISION MADE: 09-JUN-15
Bountiful UT  84010               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: smARTrack Feeding Tube System
ART Healthcare Ltd.               510(k) NO: K142327(Traditional)
ATTN: Liron  Elia                 PHONE NO : 972 9 7711065 
7 Hashlosha St.                   SE DECISION MADE: 08-JUN-15
Even-Yehuda  IL 4053423           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: DuraSheath Introducer Sheath System
CONTRACT MEDICAL INTERNATIONAL GMB510(k) NO: K142357(Traditional)
ATTN: JAN  KLOBOUCNIK             PHONE NO : 420 494949 564 
LAUENSTEINER STR, 37              SE DECISION MADE: 25-JUN-15
DRESDEN  DE 01277                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Urinary Incontinence System
GUANGZHOU FINECURE MEDICAL EQUIPME510(k) NO: K142369(Traditional)
ATTN: Chiping  Ma                 PHONE NO : 86 020 23329169 
F19, NO. 1 KESHENG ROAD, BAIYUN TOSE DECISION MADE: 17-JUN-15
GUANGZHOU  CN 510040              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Luma Wrap
Salter Labs                       510(k) NO: K142416(Traditional)
ATTN: Aurelia  Browndridge        PHONE NO : 760 7957102 
2365 Camino Vida Roble            SE DECISION MADE: 12-JUN-15
Carlsbad CA  92011                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Fixtemp Cement
EXACTA DENTAL DIRECT, INC         510(k) NO: K142446(Traditional)
ATTN: JOHN  PANKUCH               PHONE NO : 800 474 7665 
44780 MACOMB INDUSTRIAL DR.,      SE DECISION MADE: 04-JUN-15
CLINTON TOWNSHIP MI  48036        510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: OsteoCool V-2 RF Ablation System
BAYLIS MEDICAL COMPANY INC.       510(k) NO: K142480(Traditional)
ATTN: MEGHAL  KHAKHAR             PHONE NO : 905 6024875 
2645 MATHESON BLVD. EAST          SE DECISION MADE: 16-JUN-15
MISSISSAUGA, ONTARIO  CA L4W 5S4  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: IMED-Z FLUID STATUS MONITOR
INTERSECTION MEDICAL, INC.        510(k) NO: K142503(Traditional)
ATTN: WARREN  CRAYCROFT           PHONE NO : 760 5713861 211
1808 ASTON AVE STE 120            SE DECISION MADE: 05-JUN-15
CARLSBAD CA  92008-7364           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Personalized Physiology Analytics Engine software
VGBio, Inc (DBA PhysIQ)           510(k) NO: K142512(Traditional)
ATTN: Gary  Conkright             PHONE NO : 630 2515214 
1415 West Diehl Road, Suite 150   SE DECISION MADE: 11-JUN-15
Naperville IL  60563              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: HumaPen Luxura
ELI LILLY AND COMPANY             510(k) NO: K142518(Traditional)
ATTN: LeeAnn  Chambers, MS., RAC  PHONE NO : 317 2771813 
LILLY CORPORATE CENTER            SE DECISION MADE: 05-JUN-15
INDIANAPOLIS IN  46285            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: MIDSLEEVE
MEDICAL INNOVATION DEVELOPMENT    510(k) NO: K142548(Traditional)
ATTN: Melanie   Fouilland         PHONE NO : 33 478 174804 
9, CHEMIN DU JUBIN                SE DECISION MADE: 23-JUN-15
Dardilly  FR                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ELEVATE Spinal System
Medtronic Sofamor Danek USA, Inc. 510(k) NO: K142559(Traditional)
ATTN: Becky  Ronner               PHONE NO : 901 3963133 
1800 Pyramid Place                SE DECISION MADE: 09-JUN-15
Memphis TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: PANTHER Endo Linear Cutter Staplers with Single Use Loading Units
B.J.Z.H.F. Panther Medical Equipme510(k) NO: K142577(Traditional)
ATTN: Liu  Yu                     PHONE NO : 
ROM 805, Ruichuang Mansion, NO. 9 SE DECISION MADE: 11-JUN-15
Beijing  CN                       510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I and II
ORTHO CLINICAL DIAGNOSTICS        510(k) NO: K142595(Traditional)
ATTN: Bradley P Boyer             PHONE NO : 1 585 4533421 
100 INDIGO CREEK DRIVE            SE DECISION MADE: 04-JUN-15
ROCHESTER NY  14626               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Infusomat Space Volumetric Infusion Pump
B. Braun Medical Inc.             510(k) NO: K142596(Traditional)
ATTN: Gary  Johnson               PHONE NO : 610 2660500 
901 Marcon Boulevard              SE DECISION MADE: 18-JUN-15
Allentown PA  18109               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Opto Wire and OptoMonitor System 
Opsens, Inc.                      510(k) NO: K142598(Traditional)
ATTN: Vanessa  Mootoosamy         PHONE NO : 418 6829996 
2014 Rue Cyrille Duquet, #125     SE DECISION MADE: 12-JUN-15
Quebec  CA G1N 4N6                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Invia Liberty Negative Pressure Wound Therapy System, Invia Liberty Tubing Set, Y-connector, Drain Adaptor, Invia Liberty Canisters
MEDELA, AG                        510(k) NO: K142626(Traditional)
ATTN: Orlando  Antunes            PHONE NO : 41 041561 6671 
Lattichstrasse 4b                 SE DECISION MADE: 12-JUN-15
Baar  CH 6341                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Vitalograph Model 6600 Compact
VITALOGRAPH(IRELAND) LTD.         510(k) NO: K142642(Traditional)
ATTN: Tom J Healy                 PHONE NO : 353 656 864100 
Gort Road Business Park           SE DECISION MADE: 30-JUN-15
ENNIS  IE                         510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Avenue T TLIF Cage
LDR SPINE USA INC.                510(k) NO: K142645(Traditional)
ATTN: BRADLEY W. STRASSER         PHONE NO : 
13785 RESEARCH BOULEVARD SUITE 200SE DECISION MADE: 11-JUN-15
AUSTIN TX  78750                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: CARESCAPE R860
Datex-Ohmeda, Inc.                510(k) NO: K142679(Traditional)
ATTN: Trishia  Dwyer              PHONE NO : 608 2211551 
3030 Ohmeda Drive, PO Box 7550    SE DECISION MADE: 12-JUN-15
Madison WI  53707-7550            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: JiveX
VISUS TECHNOLOGY TRANSFER GMBH    510(k) NO: K142750(Traditional)
ATTN: Axel  Schreiber             PHONE NO : 49 234 93693 0
Universitatsstrasse 136           SE DECISION MADE: 26-JUN-15
Bochum  DE 44797                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Chang Gung "ComMed" Series Dental Implant System
Chang Gung Medical Technology Co.,510(k) NO: K142751(Traditional)
ATTN: Chao-Chun  Chiu             PHONE NO : 886 2 87122948 
11F., No. 201-4, Dun Hua North Rd.SE DECISION MADE: 15-JUN-15
Taipei City  TW 10508             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System, Nex-Link OCT Cervical Plating System, Sequoia Pedicle Screw System including SpeedLink II, ST360º Spinal Fixatoin System, Title 2 Polyaxial Spinal System
ZIMMER SPINE, INC.                510(k) NO: K142752(Traditional)
ATTN: DONNA M. SEMLAK             PHONE NO : 1 952 8575643 
7375 BUSH LAKE RD.                SE DECISION MADE: 18-JUN-15
MINNEAPOLIS MN  55439             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Powered Wheelchair
AAT ALBER ANTRIEBSTECHNIK GMBH    510(k) NO: K142770(Traditional)
ATTN: Mrs.Stefanie D Bankston     PHONE NO : 49 7431 12950 
EHESTETTER WEG 11                 SE DECISION MADE: 09-JUN-15
ALBSTADT-EBINGEN  DE D-72458      510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: HEARTWAY Electrically Powered Wheelchair P27
HEARTWAY Medical Products Co., Ltd510(k) NO: K142783(Traditional)
ATTN: JEN  KE-MIN                 PHONE NO : 886 4 2358353 
No.6 Road 25, Taichung Industrial SE DECISION MADE: 12-JUN-15
Taichung City  TW 40850           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Ontex Unscented Tampons with Colored Plastic Applicators
ONTEX BVBA                        510(k) NO: K142786(Traditional)
ATTN: Henri  Lesage               PHONE NO : 32 93 767706 
5 Genthof                         SE DECISION MADE: 23-JUN-15
Buggenhout  BE 9255               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Everyway Facial MENS
EVERYWAY MEDICAL INSTRUMENTS CO., 510(k) NO: K142794(Traditional)
ATTN: ROBERT  TU                  PHONE NO : 886 2 26620038 
3FL, NO.5, LANE 155, SEC. 3 PERISHSE DECISION MADE: 02-JUN-15
SHEN KENG HSIANG, TAIPEI HSIEN  TW510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: I.V. Catheter
Jiangxi Sanxin Medtec Co., Ltd    510(k) NO: K142797(Traditional)
ATTN: Bingrong  Liu               PHONE NO : 86 791 85950238 
No. 999, Fushan Road, Xiaolan EconSE DECISION MADE: 18-JUN-15
Nanchang  CN 330200               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Vitalograph Model 6800 Pneumotrac
VITALOGRAPH(IRELAND) LTD.         510(k) NO: K142812(Traditional)
ATTN: Tom J Healy                 PHONE NO : 353 656 864100 
Gort Road Business Park           SE DECISION MADE: 29-JUN-15
ENNIS  IE                         510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial
BIOMET MANUFACTURING LLC          510(k) NO: K142814(Traditional)
ATTN: TRACY BICKEL JOHNSON        PHONE NO : 574 3721761 
56 EAST BELL DR.                  SE DECISION MADE: 25-JUN-15
WARSAW IN  46581                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Ophthalmed Bending Laser Probes
OPHTHALMED LLC                    510(k) NO: K142830(Traditional)
ATTN: JAY  MANSOUR                PHONE NO : 770 7776613 
1050 Northfield Ct Ste 280        SE DECISION MADE: 25-JUN-15
ROSWELL GA  30076                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: INTRAGen
JEISYS MEDICAL, INC.              510(k) NO: K142833(Traditional)
ATTN: Kyung Won Hwang             PHONE NO : 82 2 26036417 
307 DAERUNG TECHNO TOWER 8TH, 481-SE DECISION MADE: 04-JUN-15
SEOUL  KR 153-775                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: DiscoverEEG System, Model DE-401
NeuroWave Systems Inc.            510(k) NO: K142834(Traditional)
ATTN: Tatjana  Zikov              PHONE NO : 216 4726337 
2490 Lee Blvd, Suite 300          SE DECISION MADE: 23-JUN-15
Cleveland Heights OH  44118       510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Iliad Pedicle Screw System and Zenius Pedicle Screw System
MEDYSSEY USA, INC.                510(k) NO: K142835(Traditional)
ATTN: JOHN  KUCZYNSKI             PHONE NO : 847 4270200 
1550 E. HIGGINS ROAD, SUITE 123   SE DECISION MADE: 12-JUN-15
ELK GROVE VILLAGE IL  60007       510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ABL800 FLEX with AQURE connectivity
Radiometer Medical Aps.           510(k) NO: K142898(Special)
ATTN: Lasse   Post Moller         PHONE NO : 45 38 273436 
Aakandevej 21                     SE DECISION MADE: 17-JUN-15
Broenshoej  DK 2700               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: APTUS Wrist 2.5 System
MEDARTIS AG                       510(k) NO: K142906(Traditional)
ATTN: Andrea  Schweizer           PHONE NO : 41 61633 3434 
HOCHBERGERSTRASSE 60E             SE DECISION MADE: 09-JUN-15
BASEL  CH CH-4057                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Merits Yoga Power Scooter, S542
MERITS HEALTH PRODUCTS CO., LTD.  510(k) NO: K142912(Abbreviated)
ATTN: Vincent  Chen               PHONE NO : 886 4 23594985 200
NO.18 JINGKE RD. NANTUN DIST      SE DECISION MADE: 23-JUN-15
TAICHUNG CITY  TW 40852           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: KM Needles (Acupuncture Needle)
K.M.S. INC.                       510(k) NO: K142920(Traditional)
ATTN: CHUL  HUI KIM               PHONE NO : 82 41 5587785 
F2, 81-1 HAENFJEONG-RI, GWANGDEOK-SE DECISION MADE: 10-JUN-15
CHEONAN-SI  KR 330922             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved
COVIDIEN                          510(k) NO: K142934(Traditional)
ATTN: Deborah   Fleetham          PHONE NO : 763 2104091 
161 Cheshire Lane Suite 100       SE DECISION MADE: 17-JUN-15
Plymouth MN  55441                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Metallic Locking Bone Plate and Screw System
Changzhou Dingjian Medical Applian510(k) NO: K143002(Traditional)
ATTN: Li  Qingsong                PHONE NO : 0086 135 84330156 
No.19 Juxiang Road, Wujin EconomicSE DECISION MADE: 05-JUN-15
Changzhou   CN 213149             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: iPulse Smooth Skin Gold Hair Removal System
Ipulse Limited                    510(k) NO: K143003(Traditional)
ATTN: Mike  Kiernan               PHONE NO : 44 1792 485519 
Technium 2, Kings Road, The Docks SE DECISION MADE: 18-JUN-15
Swansea   GB Sa1 8pJ              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: LiverMultiScan
MIRADA MEDICAL LTD.               510(k) NO: K143020(Third Party - Traditional)
ATTN: Gwilym  Owen                PHONE NO : 44 1865 261410 
OXFORD CENTRE FOR INNOVATION NEW RSE DECISION MADE: 23-JUN-15
OXFORD  GB OX1 1BY                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018" over the wire Catheter
Natec Medical Ltd                 510(k) NO: K143041(Special)
ATTN: Xavier  De Buchere          PHONE NO : 230 466 3054 
Maeva Centre Building Ebene BusineSE DECISION MADE: 04-JUN-15
Reduit  MU 72201                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Nacera Pearl
DOCERAM MEDICAL CERAMICS GMBH     510(k) NO: K143071(Traditional)
ATTN: Stefan  Drude               PHONE NO : 49 231 925025 952
 HESSLINGSWEG  65-67              SE DECISION MADE: 26-JUN-15
DORTMUND, NRW  DE D-44309         510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: VX120 Ophthalmic Diagnostic Device
LUNEAU SAS                        510(k) NO: K143086(Traditional)
ATTN: Isabelle  Durand            PHONE NO : 0033 2 37252525 
1 avenue de Malaguet              SE DECISION MADE: 01-JUN-15
Prunay le Gillon  FR 28360        510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: LUMINESSE PRE-SINTERED ZIRCONIA COLORING LIQUID
TALLADIUM, INC.                   510(k) NO: K143090(Traditional)
ATTN: ELINA  FASKHUTDINOVA        PHONE NO : 1 661 2950900 152
27360 WEST MUIRFIELD LN.          SE DECISION MADE: 15-JUN-15
VALENCIA CA  91355                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: 0.018" Arrow GPSCath Balloon Dilatation Catheter (150 cm)
HOTSPUR TECHNOLOGIES, INC.,       510(k) NO: K143093(Traditional)
ATTN: Eric  Ankerud, JD           PHONE NO : 1 978 3029467 
880 MAUDE AVENUE, SUITE A         SE DECISION MADE: 24-JUN-15
MOUNTAIN VIEW  CA  94043          510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: GALAXY MIS Screw System
BM KOREA                          510(k) NO: K143110(Traditional)
ATTN: JUNE  HAN                   PHONE NO : 82 31 4513294 
325-26 DANGJEONG-DONG             SE DECISION MADE: 24-JUN-15
GUNPO-SI  KR 435832               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: AOS Clavicle Intramedullary Device
ADVANCED ORTHOPAEDIC SOLUTIONS, IN510(k) NO: K143204(Traditional)
ATTN: ANNA  HWANG                 PHONE NO : 310 5339966 
3203 KASHIWA STREET               SE DECISION MADE: 03-JUN-15
TORRANCE CA  90505                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with Preservative (OTC)
Roosin Medical Devices Co., Ltd   510(k) NO: K143335(Traditional)
ATTN: Chengyu  Shen               PHONE NO : 086 523 86908085 
8 Yuandong Road, KouAn Town, GaogaSE DECISION MADE: 01-JUN-15
Taizhou  CN 225321                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Phasix ST Mesh
C. R. Bard Inc                    510(k) NO: K143380(Traditional)
ATTN: Tony  John                  PHONE NO : 1 401 8258692 
100 Crossing Boulevard            SE DECISION MADE: 05-JUN-15
Warwick RI  02886                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: GE333 Blood Glucose Monitoring System
Bionime Coporation                510(k) NO: K143387(Traditional)
ATTN: Tino  Lee                   PHONE NO : 886 4 23692388 
No. 100, Sec. 2, Daqing St., SouthSE DECISION MADE: 03-JUN-15
Taichung  TW 40242                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ICIS View
Agfa HealthCare N.V.              510(k) NO: K143397(Traditional)
ATTN: JODI  COLEMAN               PHONE NO : 519 7466210 
Septestraat 27                    SE DECISION MADE: 01-JUN-15
Mortsel  BE B-2640                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Plato MICROCATH 27B Microcatheter
SCIENTIA VASCULAR , LLC           510(k) NO: K143398(Third Party - Traditional)
ATTN: Sharon  Rockwell            PHONE NO : 714 6959269 
2700 SOUTH 900 WEST SUITE D       SE DECISION MADE: 26-JUN-15
SALT LAKE CITY UT  84119          510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: TRAUS ENDO
SAESHIN PRECISION CO., LTD.       510(k) NO: K143411(Traditional)
ATTN: Sae Kwan  Choi              PHONE NO : 82 53580 0984 
52, Secheon-ro 1-gil, Dasa-eup, DaSE DECISION MADE: 29-JUN-15
Daegu  KR 711814                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Cardio-TriTest
CARDIO-PHOENIX INC.               510(k) NO: K143432(Traditional)
ATTN: MARC  BISNAIRE              PHONE NO : 416 5950795 
2102-65 SPRING GARDEN AVE         SE DECISION MADE: 03-JUN-15
TORONTO  CA M2N 6H9               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Droplet Pen Needles, Haemofine Pen Needles
HTL-STREFA S.A.                   510(k) NO: K143437(Traditional)
ATTN: Aleksandra  Prazmowska-WilanPHONE NO : 48 42 2700270 
Adamowek 7                        SE DECISION MADE: 25-JUN-15
Ozorkow  PL 95-035                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Flowtron ACS900
Getinge (Suzhou) Co., Ltd         510(k) NO: K143438(Traditional)
ATTN: Lenda  Hou                  PHONE NO : 86 512 69561599 
No. 158 Fangzhou Road             SE DECISION MADE: 23-JUN-15
Suzhou  TW 215024                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ADH 200 Analyzer Software
ADAMS MEDITECH LLC                510(k) NO: K143449(Traditional)
ATTN: CECILIA L. YU               PHONE NO : 1 626 8542126 
17890 Castleton Street, Suite 302 SE DECISION MADE: 26-JUN-15
City of Industry CA  91748        510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Hemogrip Patch
REMEDIUM TECHNOLOGIES, INC.       510(k) NO: K143466(Traditional)
ATTN: JOHN  GUSTIN                PHONE NO : 1 301 4053585 
387 TECHNOLOGY DR. SUITE 3110B    SE DECISION MADE: 08-JUN-15
COLLEGE PARK MD  20742            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Artemis Hand Held Imaging System 
QUEST MEDICAL IMAGING             510(k) NO: K143474(Traditional)
ATTN: MARTIN  HEUVELMANS          PHONE NO : 31 227 604046 
INDUSTRIEWEG 41                   SE DECISION MADE: 30-JUN-15
MIDDENMEER  NL 1775 PW            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Digi-One 
RIMED LTD.                        510(k) NO: K143476(Special)
ATTN: AHAVA  STEIN                PHONE NO : 972 9 7484425 
25 HACHAROSHET ST.,P.O.BOX 2402  ISE DECISION MADE: 23-JUN-15
RAANANA  IL 4365613               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: BioZorb Marker
FOCAL THERAPEUTICS                510(k) NO: K143484(Traditional)
ATTN: George  Hermann             PHONE NO : 1 650 5302394 
4370 ALPINE RD. #101              SE DECISION MADE: 29-JUN-15
PORTOLA VALLEY CA  94028          510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Zimmer Patient-Specific Abutment, Internal Hex, Titanium
Zimmer Dental, Inc.               510(k) NO: K143505(Traditional)
ATTN: Christina  Boydston         PHONE NO : 1 760 9294300 
1900 Aston Ave.                   SE DECISION MADE: 25-JUN-15
Carldsbad CA  92008               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ZIO SR ECG Monitoring Service
iRhythm Technologies, Inc.        510(k) NO: K143513(Traditional)
ATTN: Rich  Laguna                PHONE NO : 415 6325700 
650 Townsend Street, Ste 380      SE DECISION MADE: 19-JUN-15
San Francisco CA  94103           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: SPSmedical VH202 External Indicator (Container Cards), SPSmedical VH202 External Indicator (Label)
CROSSTEX                          510(k) NO: K143520(Traditional)
ATTN: Michael G Nolan             PHONE NO : 585 3590310 
6789 WEST HENRIETTA ROAD          SE DECISION MADE: 09-JUN-15
RUSH NY  14543                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Fiber Disks and Blocks (TRINIA)
Bicon, LLC                        510(k) NO: K143524(Traditional)
ATTN: Richard  Wu                 PHONE NO : 800 8824266 
501 Arborway                      SE DECISION MADE: 02-JUN-15
Boston MA  02130                  510(k) STATEMENT
                                                    
 
DEVICE: XP1000 RF
BTL INDUSTRIES, INC               510(k) NO: K143559(Traditional)
ATTN: Jan  Zarsky                 PHONE NO : 866 2851656 
47 Loring Drive                   SE DECISION MADE: 11-JUN-15
Framingham MA  01702              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: WIRION
GARDIA MEDICAL                    510(k) NO: K143570(Traditional)
ATTN: OHAD  HAAS                  PHONE NO : 972 4627 7166 318
2 Ha'Eshel Street                 SE DECISION MADE: 04-JUN-15
Caesarea  IL 38900                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK, Intersomatic Transforaminal - TLIF PEEK 
Osteomed Implantes, LTDA          510(k) NO: K143572(Traditional)
ATTN: Niderdani   Ragonha         PHONE NO : 19 3532 3411 
Washington Luiz Road, km 172, CondSE DECISION MADE: 10-JUN-15
Rio Claro  BR 13501-600           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Arrow Epidural Catheter Kit
Teleflex Medical, Inc.            510(k) NO: K143581(Traditional)
ATTN: Angela  Bouse               PHONE NO : 1 919 4334904 
3015 Carrington Mill Blvd         SE DECISION MADE: 26-JUN-15
Morrisville NC  27560             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Alevicyn SG Antipruritic Gel
OCULUS INNOVATIVE SCIENCES        510(k) NO: K143590(Traditional)
ATTN: Brian W Martin              PHONE NO : 707 2830550 
1129 N MCDOWELL BLVD              SE DECISION MADE: 04-JUN-15
PETALUMA CA  94954                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Alvision Interventional Cardiology Diagnostic Catheter, Alvicath Endovascular Diagnostic Catheters
ALVIMEDICA TIBBI URUNLER SANAYI VE510(k) NO: K143604(Traditional)
ATTN: BASAK  DEMIRCI              PHONE NO : 90 212 7866080 
MANOLYA SOKAK NO:7                SE DECISION MADE: 25-JUN-15
CATALCA  TR 34540                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: dynaMX Compression Staple
MX Orthopedics, Corp.             510(k) NO: K143622(Traditional)
ATTN: Howard  L. Schrayer         PHONE NO : 1 978 2948114 
12 Suburban Park Drive            SE DECISION MADE: 17-JUN-15
Billerica MA  01821               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Propeller Model 2014-D Sensor
Reciprocal Labs                   510(k) NO: K143671(Traditional)
ATTN: David  Hubanks              PHONE NO : 1 608 2510470 
634 W. Main Street, Suite 102     SE DECISION MADE: 19-JUN-15
Madison WI  53703                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
Better Plastic Co., Ltd.          510(k) NO: K143715(Traditional)
ATTN: Du  Wei                     PHONE NO : 86 311 67699656 
No.55, Yuhua East Rd              SE DECISION MADE: 05-JUN-15
Shijiazhuang  CN 050000           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: XLR8 PLUS (XLR8+)
GENADYNE BIOTECHNOLOGIES, INC.    510(k) NO: K143726(Traditional)
ATTN: CHIEN MING GOH              PHONE NO : 516 4878787 
16 MIDLAND AVE                    SE DECISION MADE: 19-JUN-15
HICKSVILLE NY  11801              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: GBR System
JEIL MEDICAL CORPORATION          510(k) NO: K143730(Traditional)
ATTN: HYEROUNG   LEE              PHONE NO : 82 2850 3500 
702-706, 804, 805,807,812-HO ,55, SE DECISION MADE: 10-JUN-15
SEOUL  KR 152-728                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: iNSIGHT Color Doppler Ultrasound System
SASET (CHENGDU) INC.              510(k) NO: K150002(Traditional)
ATTN: Dong Chyuan Liu             PHONE NO : 86 288 5130926808 
A-601, Huoju Building, #16 ChuangySE DECISION MADE: 23-JUN-15
CHENGDU  CN 610041                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: CreoDent Solidex Customized Abutment
CREODENT PROSTHETICS, LTD.        510(k) NO: K150012(Traditional)
ATTN: CALVIN  SHIM                PHONE NO : 212 3023860 
29 WEST 30TH STREET, 11TH FLOOR   SE DECISION MADE: 04-JUN-15
NEW YORK NY  10001                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: VS3-IR-MMS System
Visionsense Ltd.                  510(k) NO: K150018(Traditional)
ATTN: Alex  Chanin                PHONE NO : 972 3924 4339 
20 Hamagshimim Street             SE DECISION MADE: 17-JUN-15
Petach Tikva, Hamerkaz  IL 49348  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Habib EUS RFA
EMCISION, LTD.                    510(k) NO: K150029(Traditional)
ATTN: FRANCOIS  POULIN            PHONE NO : 514 994 9649 
DUCANE ROAD                       SE DECISION MADE: 24-JUN-15
LONDON  GB W12 0HS                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: AMT Enteral Transition Adapters
APPLIED MEDICAL TECHNOLOGY, INC.  510(k) NO: K150034(Traditional)
ATTN: JOSHUA  MEINKE              PHONE NO : 440 7174000 
8006 KATHERINE BOULEVARD          SE DECISION MADE: 09-JUN-15
BRECKSVILLE OH  44141             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: CORA (Coagulation Resonance Analysis) System
Coramed Technologies, LLC         510(k) NO: K150041(Traditional)
ATTN: Norman E Brunner            PHONE NO : 847 6478800 16
6225 W. Howard St.                SE DECISION MADE: 26-JUN-15
Niles IL  60714                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: PleuraFlow System
ClearFlow, Inc.                   510(k) NO: K150042(Traditional)
ATTN: Dov  Gal                    PHONE NO : 1 714 9165010 
1630 S.Sunkist St, Suite E        SE DECISION MADE: 02-JUN-15
Anaheim CA  92806                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: STALIF C; STALIF C-Ti
Centinel Spine, Inc.              510(k) NO: K150053(Traditional)
ATTN: John  Parry                 PHONE NO : 1 484 8878813 
900 Airport Road, Suite 3B        SE DECISION MADE: 24-JUN-15
West  Chester PA  19380           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Elevate Moisturizing Spray
ELEVATE ORAL CARE                 510(k) NO: K150074(Traditional)
ATTN: STEVE  PARDUE               PHONE NO : 1 877 8669113 
346 PIKE ROAD SUITE 5             SE DECISION MADE: 19-JUN-15
WEST PALM BEACH FL  33411         510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L
DONG IL TECHNOLOGY LTD.           510(k) NO: K150076(Traditional)
ATTN: DONG BUM KIM                PHONE NO : 82 31 2995500 
28 NAMYANG-RO 930BEON-GIL         SE DECISION MADE: 02-JUN-15
HWASEONG-SI, GYEONGGI-DO  KR 445-0510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K150080(Third Party - Special)
ATTN: Zhai  Pei                   PHONE NO : 86 755 81885604 
MINDRAY BUILDING, KEJI 12TH RD SOUSE DECISION MADE: 12-JUN-15
NANSHAN,SHENZHEN, P.R. CHINA  CN 5510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: NanoKnife System
ANGIODYNAMICS, INC.               510(k) NO: K150089(Traditional)
ATTN: Suzanne  Goodman            PHONE NO : 508 6587942 
26 FOREST STREET                  SE DECISION MADE: 18-JUN-15
MARLBOROUGH MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Pulse Oximeter, Models PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5; PC-60D; PC-60D2; PC-60E; PC-60N; POD-1; POD-2; POD-3; PC-68A; PC-68B; PC-68C; POD- 1W; and POD-60NW-1
SHENZHEN CREATIVE INDUSTRY CO., LT510(k) NO: K150093(Special)
ATTN: JIA  WANG                   PHONE NO : 86 755 26431671 
2/F, BLOCK 3, NANYOU TIAN'AN INDUSSE DECISION MADE: 03-JUN-15
SHENZHEN CITY  CN 518054          510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Arrow Pressure-Injectable JACC with Sustain Antithrombogenic Technology
Arrow International ( a subsidiary510(k) NO: K150109(Traditional)
ATTN: Karl J Nittinger            PHONE NO : 1 610 3780131 
2400 Bernville Rd.                SE DECISION MADE: 05-JUN-15
Reading PA  19605                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Fusion Black Powder-Free Nitrile Exam Glove
Halyard Health                    510(k) NO: K150113(Abbreviated)
ATTN: Christine L Macauley        PHONE NO : 1 770 5878000 
1400 Holcomb Bridge Rd.           SE DECISION MADE: 18-JUN-15
Roswell GA  30076                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: PALACOS R pro
HERAEUS MEDICAL GMBH              510(k) NO: K150119(Special)
ATTN: ASTRID   MARX               PHONE NO : 49 618135 2963 
PHILIPP-REIS-STR. 8-13            SE DECISION MADE: 17-JUN-15
WEHRHEIM  DE 61273                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: DIVERGENCE-L Anterior/Oblique Lumbar Fusion System
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K150135(Traditional)
ATTN: LILA  JOE                   PHONE NO : 901 3963133 
1800 PYRAMID PLACE                SE DECISION MADE: 11-JUN-15
MEMPHIS TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: MCL 31 Dermablate
ASCLEPION LASER TECHNOLOGIES GMBH 510(k) NO: K150140(Traditional)
ATTN: Antje  Katzer               PHONE NO : 49 3641 7700309 
BRUESSELER STR. 10                SE DECISION MADE: 05-JUN-15
JENA  DE 07747                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: V60 Anesthetic Vaporizer
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K150167(Traditional)
ATTN: TANG  HO                    PHONE NO : 86 755 26582888 
MINDRAY BUILDING, KEJI 12TH RD SOUSE DECISION MADE: 30-JUN-15
NANSHAN,SHENZHEN, P.R. CHINA  CN 5510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Dymaxeon Spine System
Back 2 Basics Direct, LLC         510(k) NO: K150184(Traditional)
ATTN: Scot  Miller                PHONE NO : 216 4475025 
6701 Rockside Road Suite 200      SE DECISION MADE: 15-JUN-15
Independence OH  44131            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Chariot Guiding Sheath
BOSTON SCIENTIFIC CORP.           510(k) NO: K150186(Traditional)
ATTN: KURTIS  HUNSBERGER          PHONE NO : 1 763 4941204 
ONE SCIMED PLACE                  SE DECISION MADE: 05-JUN-15
MAPLE GROVE MN  55311             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Neodent Implant System
JJGC INDUSTRIA E COMERCIO DE MATER510(k) NO: K150199(Traditional)
ATTN: Jacson  Cambruzzi           PHONE NO : 55 41 21694058 
AVE JUSCELINO KUBITSCHEK DE OLIVEISE DECISION MADE: 15-JUN-15
CURITIBA    BR 81270              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Synergy Cranial
MEDTRONIC NAVIGATION, INC.        510(k) NO: K150216(Traditional)
ATTN: KAYE E. WAITE               PHONE NO : 720 8903391 
826 COAL CREEK CIRCLE             SE DECISION MADE: 11-JUN-15
LOUISVILLE CO  80027              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Fill-Up!
COLTENE/WHALEDENT AG              510(k) NO: K150218(Traditional)
ATTN: SILKE  WALLASCHEK           PHONE NO : 41 071 7575852 
FELDWIESENSTRASSE 20              SE DECISION MADE: 23-JUN-15
ALTSTATTEN  CH 9450               510(k) STATEMENT
                                                    
 
DEVICE: Navigated Disc Prep Instruments and CAPSTONE Trials
MEDTRONIC SOFAMOR DANEK USA, INC  510(k) NO: K150231(Traditional)
ATTN: Nicholas  Tabrizi           PHONE NO : 1 901 3963133 
1800 PYRAMID PLACE                SE DECISION MADE: 16-JUN-15
MEMPHIS TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: SternSnap Angled Attachment
Sterngold Dental, LLC             510(k) NO: K150250(Abbreviated)
ATTN: MARIA  RAO                  PHONE NO : 1 508 2265660 
23 Frank Mossberg Drive           SE DECISION MADE: 11-JUN-15
Attleboro MA  02703               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: PreludeEASE Hydrophilic Sheath Introducer
Merit Medical Systems, Inc.       510(k) NO: K150257(Special)
ATTN: Michaela  Rivkowich         PHONE NO : 801 2084196 
1600 West Merit Parkway           SE DECISION MADE: 19-JUN-15
South Jordan UT  84095            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Remington Medical Inc. Tuohy Epidural Needles
REMINGTON MEDICAL, INC.           510(k) NO: K150266(Traditional)
ATTN: CAITLIN  SENTER             PHONE NO : 770 8888520 
6830 MEADOWRIDGE COURT            SE DECISION MADE: 04-JUN-15
ALPHARETTA GA  30005              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: PulmoVia Working Channel
SANOVAS, INC.                     510(k) NO: K150280(Traditional)
ATTN: Roy  Morgan                 PHONE NO : 1 415 7299391 
2597 Kerner Blvd                  SE DECISION MADE: 11-JUN-15
San Rafael CA  94901              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: DPZ Pedicular Fixation System
Osteomed Implantes, LTDA          510(k) NO: K150294(Traditional)
ATTN: J. D. Webb                  PHONE NO : 512 3880199 
Washington Luiz Road, km 172, CondSE DECISION MADE: 05-JUN-15
Rio Claro  BR 13501-600           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: XXL Vascular Balloon Dilatation Catheter
BOSTON SCIENTIFIC CORP.           510(k) NO: K150303(Traditional)
ATTN: Melanie  Raska              PHONE NO : 763 4942212 
ONE SCIMED PLACE                  SE DECISION MADE: 15-JUN-15
MAPLE GROVE MN  55311             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Vdrive system, Vdrive Duo, Vdrive with V-Sono
STEREOTAXIS, INC.                 510(k) NO: K150312(Traditional)
ATTN: JOHN  NADELIN               PHONE NO : 1 314 6786130 
4320 FOREST PARK AVENUE SUITE 100 SE DECISION MADE: 17-JUN-15
ST. LOUIS MO  63108               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: MICRUSFRAME 10/18, DELTAFILL 18, DELTAXSFT 10, GALAXY G3 FILL/XSFT STRETCH RESISTANT MICROCOIL DELIVERY SYSTEMS
CODMAN & SHURTLEFF, INC.          510(k) NO: K150319(Traditional)
ATTN: Hannah  Foley               PHONE NO : 305 2656810 
325 PARAMOUNT DR.                 SE DECISION MADE: 12-JUN-15
RAYNHAM MA  02767                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: COMPASS
CENTERVUE SPA                     510(k) NO: K150320(Traditional)
ATTN: ROBERTO  GABRIOTTI          PHONE NO : 39 049 7396147 
VIA SAN MARCO, 9H                 SE DECISION MADE: 30-JUN-15
PADOVA  IT 35129                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Dunamis Force DFX Suture, Size 5, Dunamis Force DFX Suture Size 2
Dunamis LLC                       510(k) NO: K150327(Traditional)
ATTN: Prithviraj  Chavan          PHONE NO : 1 731 2172533 
693 Sherling Lake Rd.             SE DECISION MADE: 29-JUN-15
Greenville AL  36037              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: FreeStyle Lite Blood Glucose Monitoring System
ABBOTT LABORATORIES               510(k) NO: K150332(Special)
ATTN: Sai Sriharshada Tatavarty   PHONE NO : 510 7495105 
1360 South Loop Road              SE DECISION MADE: 05-JUN-15
Alameda CA  94502                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES (Cobalt Blue), POWDER FREE Nitrile GLOVES (Black), POWDER FREE Nitrile GLOVES (Ice Blue)
HEBEI HONGSEN PLASTICS TECHNOLOGY 510(k) NO: K150340(Traditional)
ATTN: Shaozhang  Nan              PHONE NO : 86 0319 7295820 
ESTERN INDUSTRIAL ZONE            SE DECISION MADE: 18-JUN-15
NANGONG CITY  CN 051800           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: NuVasive CoRoent Small Interbody System
NuVasive, Incorporated            510(k) NO: K150362(Traditional)
ATTN: Martin  Yahiro              PHONE NO : 858 6385588 
7475 Lusk Blvd.                   SE DECISION MADE: 11-JUN-15
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: NOVA Dental Implants System
NOVA Implants Ltd.                510(k) NO: K150363(Traditional)
ATTN: Dan  Grimberg               PHONE NO : 972 77 3528166 
5 Yoni Nethanyhu Street           SE DECISION MADE: 29-JUN-15
Or Yehuda  IL 6037603             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac Micro-recorder, SomnoDent Herbst Advance (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent G2 (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent Fusion (Classic or Flex Retention) with DentiTrac Micro-recorder
SOMNOMED INC.                     510(k) NO: K150369(Traditional)
ATTN: KIEN T. NGUYEN              PHONE NO : 1 972 3773400 
7460 Warren Pkwy Ste 190          SE DECISION MADE: 18-JUN-15
Frisco TX  75034                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series [Model No.: MD25x0/ MD26x0]
GRANDWAY TECHNOLOGY (SHENZHEN) LIM510(k) NO: K150373(Traditional)
ATTN: Patrick  Chow               PHONE NO : 008 52 28516789 
BLOCK 6 AND 7, ZHU KENG INDUSTRIALSE DECISION MADE: 11-JUN-15
GUANG DONG  CN                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Sonoma Cancellous Bone Screw and Washer
Sonoma Orthopedics Products, Inc  510(k) NO: K150376(Traditional)
ATTN: Rick  Epstein               PHONE NO : 
3589 Westwind Blvd                SE DECISION MADE: 12-JUN-15
Santa Rosa CA  95403              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook
NICO Corporation                  510(k) NO: K150378(Traditional)
ATTN: Sean  Spence                PHONE NO : 1 317 6607118 115
250 E 96TH ST Suite 125           SE DECISION MADE: 12-JUN-15
Indianapolis IN  46240            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: TETRIC EVOFLOW BULK FILL
IVOCLAR VIVADENT AG               510(k) NO: K150393(Abbreviated)
ATTN: SANDRA  CAKEBREAD           PHONE NO : 423 235 3535 
BENDERERSTRASSE 2                 SE DECISION MADE: 09-JUN-15
SCHAAN  LI FL-9494                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Midas Touch-Nitrile Examination Gloves- Powder free, Orange, XS, Model SNAEFT-240OR-XS; Midas Touch-Nitrile Examination Gloves -Powder free, Orange, XXL, Model SNAEFT-240OR-XXL
INDUSTRIAL CLOTHINGS (PVT) LTD    510(k) NO: K150414(Traditional)
ATTN: S.N.  HARI                  PHONE NO : 94 36 5422200 
D17, SEETHAWAKA EXPORT PROCESSING SE DECISION MADE: 12-JUN-15
AVISSAWELLA  LK 10700             510(k) STATEMENT
                                                    
 
DEVICE: NilRead
Perceptive Software               510(k) NO: K150415(Traditional)
ATTN: Claudio  Gatti              PHONE NO : 416 6738175 101
120 Carlton St., Suite 217        SE DECISION MADE: 12-JUN-15
Toronto  CA M5A 4K2               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: miraDry System MD4000
MIRAMAR LABS, INC.                510(k) NO: K150419(Traditional)
ATTN: KATHY  O'SHAUGHNESSY        PHONE NO : 408 9408700 
2790 WALSH AVENUE                 SE DECISION MADE: 19-JUN-15
SANTA CLARA CA  95051             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Injection Needle
Micro-Tech (Nanjing) CO., Ltd.    510(k) NO: K150434(Traditional)
ATTN: Becky  Li                   PHONE NO : 86 25 58646378 
NO. 10 Gaoke Third Road           SE DECISION MADE: 02-JUN-15
Nanjing  CN 210032                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ToeTac Hammertoe Fixation System
RESTORE SURGICAL LLC dba Instratek510(k) NO: K150443(Traditional)
ATTN: JEFF  SEAVEY                PHONE NO : 1 281 8902020 
15200 Middlebrook Drive, Suite G  SE DECISION MADE: 04-JUN-15
Houston TX  77058                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)
ASAHI INTECC CO., LTD.            510(k) NO: K150445(Traditional)
ATTN: Yoshihiko  Fukui            PHONE NO : 81 52 7681211 
1703 WAKITA-CHO, MORIYAMA-KU      SE DECISION MADE: 30-JUN-15
NAGOYA  JP 463-0024               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ZX2 Laser System
LZR7, Inc                         510(k) NO: K150466(Traditional)
ATTN: Randy  Rinkleib             PHONE NO : 1 530 6429680 
1980 Broadway                     SE DECISION MADE: 08-JUN-15
Placerville CA  95667             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: NxStage System One
NXSTAGE MEDICAL, INC.             510(k) NO: K150472(Special)
ATTN: Mary Lou  Stroumbos         PHONE NO : 978 6874872 
350 MERRIMACK STREET              SE DECISION MADE: 04-JUN-15
LAWRENCE MA  01843                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: EOS PMP, EOS PMP Integrated
SORIN GROUP ITALIA S.R.L.         510(k) NO: K150489(Traditional)
ATTN: LUIGI  VECCHI               PHONE NO : 011 39 053529811 
86, VIA STATALE 12 NORD           SE DECISION MADE: 11-JUN-15
MIRANDOLA, MO  IT 41037           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Sensis
Siemens Medical Solutions, Inc.   510(k) NO: K150493(Traditional)
ATTN: Patricia D Jones            PHONE NO : 1 610 4483536 
51 Valley Stream Parkway          SE DECISION MADE: 30-JUN-15
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Proteus Digital Health Feedback Device
PROTEUS DIGITAL HEALTH, INC.      510(k) NO: K150494(Traditional)
ATTN: Jessie  Duong               PHONE NO : 1 650 6376171 
2600 BRIDGE PARKWAY, SUITE 101    SE DECISION MADE: 27-JUN-15
REDWOOD CITY CA  94065            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Total Knee Arthroplasty System
Responsive Orthopedics LLC        510(k) NO: K150496(Traditional)
ATTN: Doug  Kohrs                 PHONE NO : 952 2509505 
1755 Concordia Street             SE DECISION MADE: 12-JUN-15
Wayzata MN  55391                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Px PEEK IBF System
INNOVASIS, INC.                   510(k) NO: K150500(Traditional)
ATTN: Marshall  McCarty           PHONE NO : 801 2612236 
614 EAST 3900 SOUTH               SE DECISION MADE: 19-JUN-15
SALT LAKE CITY UT  84107          510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: STAR 90
SKANRAY TECHNOLOGIES PVT LTD.     510(k) NO: K150512(Traditional)
ATTN: Hema ` Singh                PHONE NO : 91 821 2407200 
# 15-17 HEBBAL INDUSTRIAL AREA    SE DECISION MADE: 17-JUN-15
MYSORE  IN 570016                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Freedom Spinal Cord Stimulator System
STIMWAVE TECHNOLOGIES INCORPORATED510(k) NO: K150517(Traditional)
ATTN: Elizabeth  Greene           PHONE NO : 800 9655134 
420 Lincoln Rd Suite 365          SE DECISION MADE: 05-JUN-15
Miami Beach FL  33139             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue Depressor 90 mm
DUPACO INC.                       510(k) NO: K150518(Traditional)
ATTN: AN  VU                      PHONE NO : 800 5464550 
4144 AVENIDA DE LA PLATA          SE DECISION MADE: 29-JUN-15
OCEANSIDE CA  92056               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: FreeStyle Freedom Lite Blood Glucose Monitoring System
Abbott Laboratories               510(k) NO: K150531(Special)
ATTN: Sai Sriharshada Tatavarty   PHONE NO : 510 7495105 
1360  South Loop Road             SE DECISION MADE: 05-JUN-15
Alameda CA  94502                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Cavitron Touch Ultrasonic Scaling System
DENTSPLY INTERNATIONAL, INC.      510(k) NO: K150535(Traditional)
ATTN: HELEN  LEWIS                PHONE NO : 717 4871332 
221 WEST PHILADELPHIA ST. SUITE 60SE DECISION MADE: 16-JUN-15
YORK PA  17401                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Reprocessed LigaSure ImpactTM Curved, Large Jaw, Open Sealer/Divider
STRYKER SUSTAINABILITY SOLUTIONS  510(k) NO: K150538(Traditional)
ATTN: SCOTT  ENGLISH              PHONE NO : 480 7635333 
1810 W. DRAKE DRIVE               SE DECISION MADE: 25-JUN-15
TEMPE AZ  85283                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Instru-Safe Instrument Protection System
SUMMIT MEDICAL, INC.              510(k) NO: K150540(Traditional)
ATTN: Nicole  Dove                PHONE NO : 1 651 7893939 
815 NORTHWEST PARKWAY, SUITE 100  SE DECISION MADE: 22-JUN-15
ST. PAUL MN  55121                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Tek RMD (Tek Robotic Mobilization Device)
MATIA ROBOTICS MEKATROIK SIS. AR-G510(k) NO: K150548(Third Party - Traditional)
ATTN: Necati  Hacikadiroglu       PHONE NO : 90 216 5402955 
Dudullu Organize Sanayi Bolgesi 3.SE DECISION MADE: 11-JUN-15
ISTANBUL  TR 34775                510(k) STATEMENT
                                  THIRD PARTY REVIEW
 
DEVICE: Reactor(TM) Trocar and Sleeve
Sharp Medical Prducts, LLC        510(k) NO: K150549(Traditional)
ATTN: Chris  Salvino              PHONE NO : 623 3630175 
7694 E. Rose Garden Lane          SE DECISION MADE: 01-JUN-15
Scottsdale AZ  85255              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS
GLOBUS MEDICAL INC.               510(k) NO: K150552(Traditional)
ATTN: Kelly J. Baker              PHONE NO : 610 9301800 
2560 GENERAL ARMISTEAD AVE.       SE DECISION MADE: 04-JUN-15
AUDUBON PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Life Fast Set, Life Regular Set
SYBRON DENTAL SPECIALTIES         510(k) NO: K150559(Special)
ATTN: Kerri  Casino               PHONE NO : 714 5167634 
1717 W. COLLINS AVENUE            SE DECISION MADE: 19-JUN-15
ORANGE CA  92867                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Safe'n'Sound Staked Passive Delivery System - Plajex version
Nemera                            510(k) NO: K150562(Abbreviated)
ATTN: James  A WERKAMP            PHONE NO : 800 5370178 
600 Deerfield Parkway             SE DECISION MADE: 02-JUN-15
Buffalo Grove IL  60089           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: LaparoVue
Buffalo Filter, LLC               510(k) NO: K150569(Third Party - Traditional)
ATTN: Pamela  Netzel              PHONE NO : 1 716 8357000 
5900 Genesee Street               SE DECISION MADE: 10-JUN-15
Lancaster NY  14086               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: ANAX OCT Spinal System
U&I Corporation                   510(k) NO: K150570(Traditional)
ATTN: Young-Geun  Kim             PHONE NO : 82 31852 0102 619
20, Sandan-ro 76beon-gil (Rd)     SE DECISION MADE: 03-JUN-15
Uijeongbu-si  KR 480859           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Modular Power Positioning System
MOTION CONCEPTS                   510(k) NO: K150574(Traditional)
ATTN: Dona  Bhamra                PHONE NO : 905 6950134 
84 CITATION DR. Unit #1           SE DECISION MADE: 30-JUN-15
CONCORD  CA L4K 3C1               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Capillus 272 Office Pro
Capillus, LLC                     510(k) NO: K150578(Traditional)
ATTN: Patricia  Schnoor           PHONE NO : 1 786 8881874 
1430 South Dixie Highway, Suite 30SE DECISION MADE: 09-JUN-15
Coral Gables FL  33146            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Tritium Sternal Cable Plate System
Pioneer Surgical Technology, Inc. 510(k) NO: K150581(Traditional)
ATTN: Sarah  Pleaugh              PHONE NO : 906 2269909 
375 River Park Circle             SE DECISION MADE: 04-JUN-15
Marquette MI  49855               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Vertaplex® High Viscosity (HV) Radiopaque Bone Cement
STRYKER CORPORATION               510(k) NO: K150582(Traditional)
ATTN: KRISTI  ASHTON              PHONE NO : 269 3895929 
4100 E. MILHAM AVENUE             SE DECISION MADE: 12-JUN-15
KALAMAZOO MI  49001               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Besmed Reusable Jet Nebulizer
BESMED HEALTH BUSINESS CORP.      510(k) NO: K150591(Traditional)
ATTN: WINNIE  CHUNG               PHONE NO : 011 8862 22902959 
NO.5, LANE116, WU-KONG 2ND RD     SE DECISION MADE: 30-JUN-15
NEW TAIPEI CITY  TW 24888         510(k) STATEMENT
                                                    
 
DEVICE: Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
HARTALEGA SDN BHD                 510(k) NO: K150593(Traditional)
ATTN: KUAN KAM HON                PHONE NO : 603 6277 1733 
C-G-1 JALAN DATARAN SD1  DATARAN SSE DECISION MADE: 09-JUN-15
BANDAR SRI DAMANSARA  MY 52200    510(k) STATEMENT
                                                    
 
DEVICE: Trevo XP ProVue Retriever (4x30mm)
Concentric Medical, Inc.          510(k) NO: K150616(Traditional)
ATTN: Rhoda M. Santos             PHONE NO : 510 4132269 
301 East Evelyn Avenue            SE DECISION MADE: 12-JUN-15
Mountain View CA  94041           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: cobas HSV 1 and 2 Test
ROCHE MOLECULAR SYSTEMS, INC.     510(k) NO: K150617(Traditional)
ATTN: DAVID W. GATES              PHONE NO : 925 7308237 
4300 HACIENDA DRIVE               SE DECISION MADE: 01-JUN-15
PLEASANTON CA  94588-2722         510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Nanova Flowable Composite
NANOVA BIOMATERIALS, INC.         510(k) NO: K150623(Traditional)
ATTN: Andrew  Ritts               PHONE NO : 573 8233114 
3806 MOJAVE CT                    SE DECISION MADE: 18-JUN-15
COLUMBIA MO  65202                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Morrison Steerable Needle
APRIOMED AB                       510(k) NO: K150625(Traditional)
ATTN: Bruno  Edling               PHONE NO : 46 18430 1440 
VIRDINGS ALLE' 28                 SE DECISION MADE: 09-JUN-15
UPPSALA  SE 75450                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, Eye Secret 55 UV Aspheric ( methafilcon A) Soft (hydrophilic) Contact lens for Daily Wear
YUNG SHENG OPTICAL CO., LTD.      510(k) NO: K150630(Traditional)
ATTN: Wen-Han  Chen               PHONE NO : 886 4 25658384 156
3F-1, NO. 6, JHONGKE ROAD, DAYA DISE DECISION MADE: 15-JUN-15
TAICHUNG CITY  TW 42881           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti
CENTINEL SPINE, INC.              510(k) NO: K150643(Traditional)
ATTN: MR. JOHN   PARRY            PHONE NO : 484 8878813 
900 AIRPORT ROAD, SUITE 3B        SE DECISION MADE: 08-JUN-15
WEST CHESTER PA  19380            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated)
YPSOMED AG                        510(k) NO: K150662(Special)
ATTN: Stephen  Affolter           PHONE NO : 0041 34424 3382 
BRUNNMATTSTRASSE 6                SE DECISION MADE: 09-JUN-15
BURGDORF  CH CH-3401              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: uNion Cervical Plate System
ulrich medical USA                510(k) NO: K150666(Traditional)
ATTN: Hans  Stover                PHONE NO : 1 636 5190268 
18221 Edison Avenue               SE DECISION MADE: 22-JUN-15
Chesterfield MD  63005            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: True Dilatation Balloon Valvuloplasty Catheter
C.R. Bard, Inc.                   510(k) NO: K150667(Traditional)
ATTN: Aaron  Conovaloff           PHONE NO : 480 3506012 
1625 W. Third St.                 SE DECISION MADE: 17-JUN-15
Tempe AZ  85281                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Freedom Cementless Femoral Component
MAXX ORTHOPEDICS, INC.            510(k) NO: K150680(Traditional)
ATTN: Gabriela  Gottlieb          PHONE NO : 484 3420092 511
531 PLYMOUTH RD., SUITE 526       SE DECISION MADE: 26-JUN-15
PLYMOUTH MEETING PA  19462        510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Jade 37% Phosphoric Acid Etchant Gel
Dharma Research, Inc.             510(k) NO: K150696(Traditional)
ATTN: Ricardo  Carles             PHONE NO : 305 4829669 
5220 NW 72nd Ave #15              SE DECISION MADE: 23-JUN-15
Miami FL  33166                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ProTrack RF Anchor Wire
BAYLIS MEDICAL COMPANY INC.       510(k) NO: K150709(Traditional)
ATTN: Meghal   Khakhar            PHONE NO : 905 6024875 
2645 MATHESON BLVD. EAST          SE DECISION MADE: 17-JUN-15
MISSISSAUGA  CA L4W 5S4           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Wi-3 HAL-RAR System
AGENCY FOR MEDICAL INNOVATIONS GMB510(k) NO: K150718(Traditional)
ATTN: Stefanie  Hoellger          PHONE NO : 43 5522 905050 
IM LETTEN 1                       SE DECISION MADE: 12-JUN-15
FELDKIRCH, VORARLBERG  AT 6800    510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: OARtrac System with Skin Sensors
RadiaDyne, LLC                    510(k) NO: K150719(Traditional)
ATTN: John K. Isham               PHONE NO : 281 7599609 
2313 W. Sam Houston Pkwy. N., SuitSE DECISION MADE: 16-JUN-15
Houston TX  77043                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ARDO Calypso Pro Powered Breast Pump
ARDO MEDICAL AG                   510(k) NO: K150721(Traditional)
ATTN: ROGER  DUBACH               PHONE NO : 41 41 7547070 
Gewerbestrasse 19                 SE DECISION MADE: 17-JUN-15
UNTERAEGERI  CH 6314              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Visaris Avanse
VISARIS d.o.o. Belgrade           510(k) NO: K150725(Traditional)
ATTN: Milan  Ratkovic             PHONE NO : 381 11 2017656 
Batajnicki drum 10 deo 1b         SE DECISION MADE: 08-JUN-15
Zemun  RS 11080                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ESTECEM
TOKUYAMA DENTAL CORPORATION       510(k) NO: K150727(Traditional)
ATTN: Fumio  Takahashi            PHONE NO : 011 81 338352261 
38-9 TAITO 1-CHOME, TAITO-KU      SE DECISION MADE: 17-JUN-15
TOKYO  JP 110-0016                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Zimmer PSI Shoulder System
ZIMMER                            510(k) NO: K150730(Traditional)
ATTN: CHRISTOPHER  MCLEAN         PHONE NO : 514 8614074 231
75, QUEEN STREET, SUITE 3300      SE DECISION MADE: 16-JUN-15
MONTREAL  CA H3C 2N6              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: OASYS System
STRYKER CORPORATION               510(k) NO: K150753(Traditional)
ATTN: Garry T Hayeck              PHONE NO : 201 7608043 
2 PEARL COURT                     SE DECISION MADE: 09-JUN-15
ALLENDALE NJ  07401               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Safety Disposable Insulin Syringe
JIANGYIN CAINA TECHNOLOGY CO., LTD510(k) NO: K150758(Traditional)
ATTN: JUN  LU                     PHONE NO : 86 510 86205183 
No. 2, Taifu Road, Huashi Town    SE DECISION MADE: 18-JUN-15
Jiangyin  CN 214421               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Ez3D-i/E3
EWOO SOFT CO., LTD                510(k) NO: K150761(Special)
ATTN: Young Seok Kim              PHONE NO : 82 31 80156171 
S-402, 231 PANGYOYEOK-RO BUNDANG-GSE DECISION MADE: 05-JUN-15
SEONGNAM  KR 463-400              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Carestream DRX-1 System
Carestream Health, Inc.           510(k) NO: K150766(Traditional)
ATTN: Carolyn L Wagner            PHONE NO : 585 6276588 
150 Verona Street                 SE DECISION MADE: 24-JUN-15
Rochester NY  14608               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Tissue Removal Pouch
BOEHRINGER LABORATORIES, LLC      510(k) NO: K150781(Traditional)
ATTN: Chris  Radl                 PHONE NO : 610 2780900 
300 Thoms Drive                   SE DECISION MADE: 19-JUN-15
Phoenixville PA  19460            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Progressive Orthopaedic Total Knee System
The Progressive Orthopaedic Compan510(k) NO: K150783(Traditional)
ATTN: Scott   Keiser              PHONE NO : 561 4404460 
801 US Highway 1, Suite B         SE DECISION MADE: 23-JUN-15
North Palm Beach FL  33408        510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Dental Bone Cutting Instruments
SYNTHES (USA) PRODUCTS, LLC       510(k) NO: K150796(Traditional)
ATTN: SUSAN  LEWANDOWSKI          PHONE NO : 610 7195852 
1301 GOSHEN PARKWAY               SE DECISION MADE: 23-JUN-15
WEST CHESTER PA  19380            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Sure Lok Mini Posterior Cervical/Upper Thoracic System
PRECISION SPINE, INC.             510(k) NO: K150851(Special)
ATTN: Michael  Dawson             PHONE NO : 601 4204244 
2050 EXECUTIVE DRIVE              SE DECISION MADE: 04-JUN-15
PEARL MS  39208                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Affixus Tibial Nailing System
BIOMET, INC.                      510(k) NO: K150867(Traditional)
ATTN: SUZANA  OTANO               PHONE NO : 305 2696386 
56 EAST BELL DRIVE                SE DECISION MADE: 10-JUN-15
WARSAW IN  46581                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Solana GAS Assay, Solana instrument
QUIDEL CORPORATION                510(k) NO: K150868(Traditional)
ATTN: RONALD H LOLLAR             PHONE NO : 740 5893373 
2005 EAST STATE STREET, SUITE 100 SE DECISION MADE: 23-JUN-15
ATHENS OH  45701                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration Verifiers
DiaSorin Inc.                     510(k) NO: K150879(Traditional)
ATTN: John  Walter                PHONE NO : 651 4399710 
1951 Northwestern Avenue          SE DECISION MADE: 22-JUN-15
Stillwater MN  55082-1482         510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Edwards Suture Fastening System 
EDWARDS LIFESCIENCES, LLC.        510(k) NO: K150882(Traditional)
ATTN: NINA  BROOKE                PHONE NO : 949 2506444 
ONE EDWARDS WAY                   SE DECISION MADE: 16-JUN-15
IRVINE CA  92614                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: SPEC Model M16
Source Production and Equipment Co510(k) NO: K150895(Traditional)
ATTN: Kelly  Richardt             PHONE NO : 504 4649471 
113 Teal Street                   SE DECISION MADE: 19-JUN-15
St. Rose LA  70087                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ACCU-CHEK Connect Diabetes Management App 
ROCHE DIABETES CARE INC.          510(k) NO: K150910(Special)
ATTN: CHUNHONG  TAO               PHONE NO : 317 5217227 
9115 HAGUE ROAD                   SE DECISION MADE: 03-JUN-15
INDIANAPOLIS  IN  46250-0457      510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: truFreeze System
CSA MEDICAL, INC.                 510(k) NO: K150920(Traditional)
ATTN: SHERRIE  COVAL-GOLDSMITH    PHONE NO : 781 5387447 
91 HARTWELL AVE                   SE DECISION MADE: 17-JUN-15
LEXINGTON MA  02421               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set
Immunalysis Corporation           510(k) NO: K150925(Traditional)
ATTN: Joseph  Ginete              PHONE NO : 909 4820840 
829 Towne Center Drive            SE DECISION MADE: 29-JUN-15
Pomona CA  91767                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Ensizor Endoscopic Scissors
SLATER ENDOSCOPY, LLC             510(k) NO: K150939(Traditional)
ATTN: JOHN  STARKEY               PHONE NO : 305 8893350 
14000 NW 58TH COURT               SE DECISION MADE: 08-JUN-15
MIAMI LAKES FL  33014             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: FibroScan
ECHOSENS                          510(k) NO: K150949(Traditional)
ATTN: CELINE  FOURNIER            PHONE NO : 33 1 44827855 
30 PLACE D'ITALIE                 SE DECISION MADE: 03-JUN-15
PARIS  FR 75013                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: aeris Balloon Dialation Catheter
Bryan Medical , Inc.              510(k) NO: K150951(Third Party - Traditional)
ATTN: ANDY  BLACK                 PHONE NO : 1 847 6207990 
3906 Oak St.                      SE DECISION MADE: 25-JUN-15
Cincinnati OH  45227              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
DEVICE: XIDF-AWS801, Angio Workstation, V6.10
Toshiba Medical Systems Corporatio510(k) NO: K150967(Traditional)
ATTN: Paul  Biggins               PHONE NO : 714 6697808 
1385 Shimoishigami                SE DECISION MADE: 18-JUN-15
Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2 multi-msrmt-modules for use with IntelliVue patient monitors
PHILIPS MEDIZIN SYSTEME BOEBLINGEN510(k) NO: K150975(Special)
ATTN: Michael  Asmalsky           PHONE NO : 49 7031 4631277 
Hewlett-Packard Str. 2            SE DECISION MADE: 25-JUN-15
Boeblingen, Baden Wuerttemberg  DE510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Collage
ANATOMAGE INC.                    510(k) NO: K150976(Traditional)
ATTN: SEAN  XU                    PHONE NO : 408 8851474 108
111 N. MARKET STREET #500         SE DECISION MADE: 04-JUN-15
SAN JOSE CA  95113                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: SMV Scientific Bone Screws
SMV Scientific                    510(k) NO: K150981(Traditional)
ATTN: Nephi  Zufelt               PHONE NO : 512 7508622 
111 Sandra Muraida Way Unit 18A   SE DECISION MADE: 23-JUN-15
Austin TX  78703                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: NuVasive CoRoent Thoracolumbar Implants
NUVASIVE, INCORPORATED            510(k) NO: K150994(Special)
ATTN: CYNTHIA  ADAMS              PHONE NO : 858 3204549 
7475 LUSK BLVD.                   SE DECISION MADE: 17-JUN-15
SAN DIEGO CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip
ATRICURE, INC.                    510(k) NO: K150996(Special)
ATTN: Brittany  Lowe              PHONE NO : 513 7555652 
6217 CENTRE PARK DRIVE            SE DECISION MADE: 17-JUN-15
WEST CHESTER OH  45069            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: MUSE System
MEDIGUS LTD.                      510(k) NO: K151001(Special)
ATTN: YANIV  SAGIE                PHONE NO : 972 8 6466880 
BUILDING 7A, OMER IMDUSTRIAL PARK SE DECISION MADE: 05-JUN-15
OMER  IL 84965                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: LOGIQ e
GE MEDICAL SYSTEMS ULTRASOUND AND 510(k) NO: K151028(Traditional)
ATTN: TRACEY  ORTIZ               PHONE NO : 1 414 6766120 
9900 INNOVATION DR.               SE DECISION MADE: 18-JUN-15
WAUWATOSA WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Virage OCT Spinal Fixation System
ZIMMER SPINE, INC                 510(k) NO: K151031(Traditional)
ATTN: DONNA M. SEMLAK             PHONE NO : 1 952 8575643 
7375 BUSH LAKE RD.                SE DECISION MADE: 24-JUN-15
MINNEAPOLIS MN  55439             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Ultrasound System SONIMAGE HS1
KONICA MINOLTA, INC.              510(k) NO: K151060(Traditional)
ATTN: Shigeyuki  Kojima           PHONE NO : 81 42 5898429 
1 SAKURA-MACHI                    SE DECISION MADE: 05-JUN-15
HINO-SHI  JP 191-8511             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: MicroCross Catheter 
ROXWOOD MEDICAL, INC.             510(k) NO: K151082(Special)
ATTN: GRACE   LI                  PHONE NO : 415 5165539 
400 SEAPORT CT, SUITE #103        SE DECISION MADE: 07-JUN-15
REDWOOD CITY CA  94063            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ASAHI Corsair Microcatheter
ASAHI INTECC CO., LTD.            510(k) NO: K151103(Traditional)
ATTN: YOSHIHIKO  FUKUI            PHONE NO : 81 52 7681211 
1703 WAKITA-CHO, MORIYAMA-KU      SE DECISION MADE: 23-JUN-15
NAGOYA  JP 463-0024               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: MR Core Software
Vital Images, Inc                 510(k) NO: K151115(Traditional)
ATTN: Parthiv  Shah               PHONE NO : 952 4879574 
5850 Opus Parkway Suite 300       SE DECISION MADE: 03-JUN-15
Minnetonka MN  55343-4414         510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: CapLOX II/TowerLOX Pedicle Screw System
CAPTIVA SPINE                     510(k) NO: K151116(Special)
ATTN: TAMALA  WAMPLER             PHONE NO : 1 877 7725571 
967 ALTERNATE A1A #1              SE DECISION MADE: 26-JUN-15
JUPITER FL  33477                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: PRECICE Intramedullary Limb Lengthening System
Ellipse Technologies, Incorporated510(k) NO: K151131(Special)
ATTN: Rebecca  Shelburne          PHONE NO : 949 8373600 
13900 Alton Parkway Ste 123       SE DECISION MADE: 19-JUN-15
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: PROBEAT-V
Hitachi, Ltd.,Health Care Company 510(k) NO: K151132(Traditional)
ATTN: Naoya  Nishimura            PHONE NO : 81 3 45643563 
4-14-1 Sotokanda, Chiyoda-ku      SE DECISION MADE: 01-JUN-15
Tokyo  JP 101-8010                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: VICTUS Femtosecond Laser Platform
TECHNOLAS PERFECT VISION GMBH     510(k) NO: K151161(Traditional)
ATTN: FRIEDRICH  MORITZ           PHONE NO : 49 89 94004494 
MESSERSCHMITTSTR. 1+3             SE DECISION MADE: 24-JUN-15
MUNICH  DE 80992                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: VariAx 2 Wrist Fusion System
Stryker Trauma AG                 510(k) NO: K151178(Traditional)
ATTN: DR. HEIKE  GUSTKE           PHONE NO : 49 4348 702637 
PROF.-KUNTSCHER-STR. 1-5          SE DECISION MADE: 24-JUN-15
SCHOENKIRCHEN  DE 24232           510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: syngo.via MI Workflows
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K151192(Traditional)
ATTN: VERONICA  PADHARIA          PHONE NO : 847 3046375 
2501 N. BARRINGTON ROAD           SE DECISION MADE: 23-JUN-15
HOFFMAN ESTATES IL  60192         510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Stryker ICONIX with Needles
Stryker                           510(k) NO: K151201(Traditional)
ATTN: TAYLOR   WHITE              PHONE NO : 303 3367285 
5670 Greenwood Plaza Blvd, Suite 2SE DECISION MADE: 29-JUN-15
Greenwood Village CO  80111       510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control Set
IMMUNALYSIS CORPORATION           510(k) NO: K151203(Traditional)
ATTN: JOSEPH  GINETE              PHONE NO : 909 4820840 
829 TOWNE CENTER DR               SE DECISION MADE: 05-JUN-15
POMONA CA  91767                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secobarbital/Oxycodone Quick Cup, AssureTech Secobarbital/Oxycodone Turn Key-Split Cup
Assure Tech. Co., Ltd             510(k) NO: K151211(Traditional)
ATTN: Eric  Lin                   PHONE NO : 86 571810 22698 
2nd. Floor, Building 1, No. 10, XiSE DECISION MADE: 04-JUN-15
Hangzhou  CN 310030               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ALIF Interfixated System
NuVasive, Incorporated            510(k) NO: K151214(Traditional)
ATTN: Cynthia  Adams              PHONE NO : 858 3204549 
7475 Lusk Boulevard               SE DECISION MADE: 25-JUN-15
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Mercury Spinal System 
Spinal Elements Inc.              510(k) NO: K151215(Special)
ATTN: JULIE  LAMOTHE              PHONE NO : 760 6071816 
3115 Melrose Dr.,Suite 200        SE DECISION MADE: 03-JUN-15
Carlsbad CA  92010                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Kubtec DIGIVIEW 395 
KUB TECHNOLOGIES, INC             510(k) NO: K151221(Traditional)
ATTN: VIKRAM  BUTANI              PHONE NO : 203 3648544 
270 ROWE AVENUE, UNIT E           SE DECISION MADE: 23-JUN-15
MILFORD CT  06461                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Lineum OCT Spine System
BIOMET SPINE                      510(k) NO: K151224(Traditional)
ATTN: Spencer  Kimber             PHONE NO : 303 5018523 
310 INTERLOCKEN PARKWAY, SUITE 120SE DECISION MADE: 30-JUN-15
BROOMFIELD CO  80021              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Arthrex FiberTak Anchors
Arthrex, Inc.                     510(k) NO: K151230(Special)
ATTN: Ivette  Galmez              PHONE NO : 239 6435553 71263
1370 Creekside Boulevard          SE DECISION MADE: 19-JUN-15
Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: JUSHA-M23C LCD Monitor
NANJING JUSHA DISPLAY TECHNOLOGY C510(k) NO: K151238(Traditional)
ATTN: Ma  Jing                    PHONE NO : 86 25 83305050 
301, HANZHONGMEN STREET, 8F BLOCK SE DECISION MADE: 12-JUN-15
MANSION, NANJING  CN 210036       510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: extriCARE Negative Pressure Wound Therapy Gel Strip - 8pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 7pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 6pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 5pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 4pc
Devon Medical Products            510(k) NO: K151240(Special)
ATTN: JOHN  SIEGEL                PHONE NO : 1 866 4460092 
1100 First Avenue, Suite 202      SE DECISION MADE: 09-JUN-15
King of Prussia PA  19406         510(k) STATEMENT
                                                    
 
DEVICE: Pre-Formed Guidewire
Lake Region Medical               510(k) NO: K151244(Special)
ATTN: Mathew  Pexa                PHONE NO : 952 4485111 
340 Lake Hazeltine Dr.            SE DECISION MADE: 11-JUN-15
Chaska MN  55318                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Aneroid Sphygmomanometer
Jiaxing Zhongfa Medical Products C510(k) NO: K151246(Traditional)
ATTN: Mao  Xiaohua                PHONE NO : 86 573 83133191 
No.38 Building 1, Zhong Fa Group ZSE DECISION MADE: 30-JUN-15
Jiaxing  CN 314008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: 2cm Peripheral Cutting Balloon Microsurgical Dilatation Catheter
BOSTON SCIENTIFIC LIMITED         510(k) NO: K151253(Special)
ATTN: LISA  MEE                   PHONE NO : 353 91 406184 
BALLYBRIT BUSINESS PARK GALWAY    SE DECISION MADE: 10-JUN-15
GALWAY  IE                        510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PAD
Cardiovascular System, Inc.       510(k) NO: K151260(Special)
ATTN: Kim  Wallner                PHONE NO : 651 2024917 
1228 Old Highway 8 NW             SE DECISION MADE: 10-JUN-15
Saint Paul MN  55112              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Henschke Titanium Applicator Set
NUCLETRON B.V.                    510(k) NO: K151272(Traditional)
ATTN: Lizette  Van de Streek      PHONE NO : 31 318 557133 
WAARDGELDER 1                     SE DECISION MADE: 23-JUN-15
VEENENDAAL  NL 3905 TH            510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: DePuy Synthes T-PAL Ti Spacer
SYNTHES USA PRODUCTS LLC          510(k) NO: K151276(Special)
ATTN: Eric  Zhu                   PHONE NO : 508 8233730 
325 Paramount Drive               SE DECISION MADE: 18-JUN-15
Raynham MA  02767                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: AGE Automatic Wrist Blood Pressure Monitor
DONGGUAN AGELESS HEALTH INDUSTRIAL510(k) NO: K151281(Traditional)
ATTN: VICTOR   WAN                PHONE NO : 86 769 81158038 
3/F, A1 BLDG, DONGSHEN SIMA INDUSTSE DECISION MADE: 30-JUN-15
DONGGUAN  CN 523560               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Disposable Blood Pressure Cuff, Reusable Blood Pressure Cuff 
XUZHOU MAICUFF TECHNOLOGY CO.,LTD.510(k) NO: K151290(Traditional)
ATTN: LI  ZHAOQIAN                PHONE NO : 86 516 85908810 
8#-2-1106, JINXIUJIAYUAN, JIANGUO SE DECISION MADE: 30-JUN-15
XUZHOU  CN 221006                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: BD Veritor (TM) System for the Rapid Detection of Flu A+B
BECTON DICKINSON AND COMPANY      510(k) NO: K151291(Special)
ATTN: GREGORY P PAYNE             PHONE NO : 858 7957890 
10865 ROAD TO THE CURE, SUITE 200 SE DECISION MADE: 10-JUN-15
SAN DIEGO CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: BD Veritor (TM) System for the Rapid Detection of Flu A + B
Becton Dickinson and Company      510(k) NO: K151301(Special)
ATTN: Gregory P Payne             PHONE NO : 858 7957890 
10865 Road to the Cure, Suite 200 SE DECISION MADE: 08-JUN-15
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified Lumenis Family of UltraPulse SurgiTouch
LUMENIS LTD                       510(k) NO: K151331(Special)
ATTN: ELISSA  BURG                PHONE NO : 972 4 9599168 
6 HAKIDMA STREET PO BOX 240       SE DECISION MADE: 30-JUN-15
YOKNEAM  IL 2069204               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Spacemaker Pro Access and Dissector System
Covidien LLC                      510(k) NO: K151356(Special)
ATTN: Rebecca   Magnanimo         PHONE NO : 203 4926479 
60 Middletown Avenue              SE DECISION MADE: 18-JUN-15
North Haven CT  06473             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade
STRYKER                           510(k) NO: K151387(Special)
ATTN: JONATHAN  SCHELL            PHONE NO : 269 3895596 
750 TRADE CENTRE WAY, SUITE 200   SE DECISION MADE: 24-JUN-15
PORTAGE MI  49002                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: K-Pack II Needle - 29G x 5/16" Thin Wall
TERUMO EUROPE N.V.                510(k) NO: K151398(Special)
ATTN: M. J. Aerts                 PHONE NO : 32 016 381211 
Interleuvenlaan 40                SE DECISION MADE: 25-JUN-15
Leuven  BE 3001                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: GF50A
SAMSUNG ELECTRONICS CO., LTD.     510(k) NO: K151419(Traditional)
ATTN: Chulsin  Kim                PHONE NO : 82 31 2007661 
129, SAMSUNG-RO YEONGTONG-GU      SE DECISION MADE: 23-JUN-15
SUWON-SI  KR 443-742              510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test
W.H.P.M., INC.                    510(k) NO: K151441(Traditional)
ATTN: JOHN  WAN                   PHONE NO : 1 626 4438480 
5358 IRWINDALE AVE.               SE DECISION MADE: 29-JUN-15
IRWINDALE CA  91706               510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: AeroDR SYSTEM 2 
KONICA MINOLTA, INC.              510(k) NO: K151465(Special)
ATTN: SHIGEYUKI  KOJIMA           PHONE NO : 81 42 5898429 
1 SAKURA-MACHI                    SE DECISION MADE: 29-JUN-15
HINO-SHI  JP 191-8511             510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: GENESIS
DORNIER MEDTECH AMERICA, INC.     510(k) NO: K151485(Special)
ATTN: JOHN   HOFFER               PHONE NO : 770 5146163 
1155 ROBERTS BLVD.                SE DECISION MADE: 30-JUN-15
KENNESAW GA  30144                510(k) SUMMARY AVAILABLE FROM FDA
                                                    
 
DEVICE: GSI TympStar Pro Middle Ear Analyzer
Diagnostic Group, dba Grason-Stadl510(k) NO: K151509(Third Party - Traditional)
ATTN: Ron  Rolfsen                PHONE NO : 952 9476064 
7625 Golden Triangle Drive, Suite SE DECISION MADE: 25-JUN-15
Eden Prairie MN  55344            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW
 
 
             TOTAL 510(k)s THIS PERIOD   265                                     
             TOTAL WITH SUMMARIES        256                                     
             TOTAL WITH STATEMENTS        9
                                       

 

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