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Medical Devices

August 2014 510(k) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD August 2014


DEVICE: SAVINA 300 SAVINA 300, COUNTRY VARIANTS
DRAEGER MEDICAL GMBH              510(k) NO: K121886(Traditional)
ATTN: BETH  ZIS                   PHONE NO : 978 379-8255 
6 TECH DR                         SE DECISION MADE: 08-AUG-14
ANDOVER MA  01810                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CAPNOSTREAM20P WITH HIFI C02 MONITORING
ORIDION MEDICAL 1987 LTD.         510(k) NO: K123690(Traditional)
ATTN: DALIA  GIVONY               PHONE NO : 972 2 5899235 
7 HAMARPE ST. HAR HOTZVIM INDUSTRISE DECISION MADE: 05-AUG-14
JERUSALEM  IL 91450               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BUZZY
MMJ LABS, LLC                     510(k) NO: K130631(Traditional)
ATTN: VALERIE  STAFFEY            PHONE NO : 877 805-2899 
322 SUTHERLAND PLACE              SE DECISION MADE: 13-AUG-14
ATLANTA GA  30307                 510(k) STATEMENT
                                                    

DEVICE: SYNTHES REUSABLE STERILIZATION CONTAINER SYSTEM
SYNTHES (USA) PRODUCTS LLC        510(k) NO: K130720(Traditional)
ATTN: THOMAS  SHEA                PHONE NO : 610 719-6809 
1302 WRIGHTS LANE EAST            SE DECISION MADE: 14-AUG-14
WEST CHESTER PA  19380            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GMATE SMART BLOOD GLUCOSE MONITORING SYSTEM, GMATE SMART APPLICATION
PHILOSYS, INC.                    510(k) NO: K131230(Traditional)
ATTN: LINDA  CHAN                 PHONE NO : 646 454-5414 
304 PARK AVENUE SOUTH SUITE 218   SE DECISION MADE: 04-AUG-14
NEW YORK NY  10010                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SONOSENTRY
ISONEA LTD                        510(k) NO: K131285(Traditional)
ATTN: KORINA  AKHONDZADEH         PHONE NO : 760 798-9641 
6965 EL CAMINO REAL SUITE 105-428 SE DECISION MADE: 19-AUG-14
CARLSBAD CA  92009                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IQ TECHNOLOGIES
IQ TECHNOLOGIES INC.              510(k) NO: K131290(Traditional)
ATTN: ELI  JOSEF                  PHONE NO : 702 556-5534 
1631 E. Sunset Road Suite C 103   SE DECISION MADE: 06-AUG-14
Las Vegas NV  89119               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ORTOMED
INFOMED SERVICIOS INFORMATICOS S.L510(k) NO: K131348(Abbreviated)
ATTN: SANTIAGO  SOLA              PHONE NO : 003 49 34144340 
VIA AUGUSTA 158, 4TH FLOOR        SE DECISION MADE: 05-AUG-14
BARCELONA  ES 08006               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KERICURE ADVANCED LIQUID BANDAGE, NATURAL SEAL LIQUID BANDAGE, LIQUID BANDAGE
KERICURE INC.                     510(k) NO: K131384(Traditional)
ATTN: JONATHAN  WARD              PHONE NO : 813 645-2855 
445 APOLLO BEACH BLVD             SE DECISION MADE: 07-AUG-14
APOLLO BEACH FL  33572            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BAHADIR STERILIZATION TRAYS
BAHADIR USA CORP.                 510(k) NO: K131407(Abbreviated)
ATTN: ISMAIL  KILIC               PHONE NO : 631 608-8522 
275 WEST HOFFMAN AVENUE           SE DECISION MADE: 12-AUG-14
LINDENHURST NY  11757             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: THUNDERBOLT AND LANCER  PEDICLE SCREW SYSTEMS
CHOICE SPINE                      510(k) NO: K132049(Traditional)
ATTN: KIM  FINCH                  PHONE NO : 865 246-3333 
400 ERIN DR.                      SE DECISION MADE: 15-AUG-14
KNOXVILLE TN  37919               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SKAFFOLD NMX BONE VOID FILLER
SKELETAL KINETICS, LLC            510(k) NO: K132211(Traditional)
ATTN: CHRISTINE  KUO              PHONE NO : 408 350-5842 
10201 BUBB RD.                    SE DECISION MADE: 04-AUG-14
CUPERTINO CA  95014-4167          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IONSIL GEL
VIRCHOW BIOTECH PVT. LTD.         510(k) NO: K132326(Traditional)
ATTN: BRUCE  GIBBINS, PHD.        PHONE NO : 503 781-7565 
5903 SE MILWAUKIE AVENUE          SE DECISION MADE: 21-AUG-14
PORTLAND OR  97202                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PREVANTICS DEVICE SWAB
PROFESSIONAL DISPOSABLES INTERNATI510(k) NO: K132380(Traditional)
ATTN: ELIZABETH  ERNST            PHONE NO : 845 608-3350 
2 NICE PAK PARK                   SE DECISION MADE: 27-AUG-14
ORANGEBURG NY  10962              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NUBRILLIANCE PULSED LIGHT HAIR REMOVAL DEVICE
WELLQUEST INTL., INC.             510(k) NO: K132518(Traditional)
ATTN: ROBERT  SEIPLE, RAC         PHONE NO : 512 327-9997 
816 CONGRESS AVE, STE 1400        SE DECISION MADE: 17-AUG-14
AUSTIN TX  78701                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EIA SMDP IMMUNOASSAY
PHADIA US INC.                    510(k) NO: K132631(Traditional)
ATTN: MARTIN  ROBERT MANN         PHONE NO : 269 492-1957 
4169 COMMERCIAL AVE.              SE DECISION MADE: 29-AUG-14
PORTAGE MI  49002                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OKMETER DIRECT BLOOD GLUCOSE MONITORING SYSTEM
OK BIOTECH CO., LTD.              510(k) NO: K132633(Traditional)
ATTN: JEN  KE-MIN                 PHONE NO : 886 351 60258 
NO. 91, SEC. 2 GONGDAOWU ROAD     SE DECISION MADE: 14-AUG-14
HSINCHU CITY  TW 30070            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PASSPORT SERIES PATIENT MONITORS
SHENZHEN MINDRAY BIOMEDICAL ELECTR510(k) NO: K132662(Special)
ATTN: YANHONG  BAI                PHONE NO : 86 755 81885635 
MINDRAY BUILDING, KEJI 12TH ROAD SSE DECISION MADE: 01-AUG-14
NANSHAN, SHENZHEN  CN 518057      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LUBRIGYN CREAM
UNIDERM FARMACEUTICI SRL          510(k) NO: K132772(Traditional)
ATTN: GUIDO  BONAPACE             PHONE NO : 39 054 2683803 
VIA A. ALTOBELLI BONETTI 3A       SE DECISION MADE: 22-AUG-14
IMOLA, BO  IT 40026               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HEARTWAY POWER MOBILITY SCOOTER
HEARTWAY MEDICAL PRODUCTS CO., LTD510(k) NO: K132855(Traditional)
ATTN: JEN  KE-MIN                 PHONE NO : 886 423 580357 
NO. 6 ROAD 25 TAICHUNG INDUSTRIAL SE DECISION MADE: 29-AUG-14
TAICHUNG CITY, TAIWAN  TW R.O.C. 4510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TEBCO-W
BOMED INC                         510(k) NO: K132892(Traditional)
ATTN: B. BO  SRAMEK, PH.D         PHONE NO : 808 885-8463 
59-440 PILI PL.                   SE DECISION MADE: 01-AUG-14
KAMUELA HI  96743                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLE
SYNAPTIC MEDICAL LIMITED          510(k) NO: K132943(Traditional)
ATTN: Diana  Hong                 PHONE NO : 86 21 22815850 
P.O. BOX 120-119                  SE DECISION MADE: 29-AUG-14
SHANGHAI  CN 200120               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TON-95LH, PAX-I3D ORTHO
VATECH CO., LTD.                  510(k) NO: K132983(Traditional)
ATTN: DAVE  KIM                   PHONE NO : 713 467-2607 
8310 BUFFALO SPEEDWAY             SE DECISION MADE: 07-AUG-14
HOUSTON TX  77025                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JETSTREAM SYSTEM
MEDRAD, INC.                      510(k) NO: K133023(Traditional)
ATTN: ARMA  RACIC                 PHONE NO : 763 450-8500 
9055 EVERGREEN BLVD. NW           SE DECISION MADE: 27-AUG-14
MINNEAPOLIS MN  55433             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FIT BELT
HONG QIANG XING (SHENZHEN) ELECTRO510(k) NO: K133108(Traditional)
ATTN: XU JIAN  HUA                PHONE NO : 86 755 26423615 
4F.,JINGCHENG BUILDING, XICHENG INSE DECISION MADE: 05-AUG-14
SHENZHEN  CN 518102               510(k) STATEMENT
                                                    

DEVICE: DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE
WRP ASIA PACIFIC SDN. BHD.        510(k) NO: K133168(Traditional)
ATTN: KIRK  PENNER                PHONE NO : 60 387 061486 
LOT 1, JALAN 3, KAWASAN PERUSAHAANSE DECISION MADE: 07-AUG-14
SALAK TINGGI, SEPANG SELANGOR  MY 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SAAD PATIENT MONITOR (SPM)
HANIN MEDICAL SERVICES CO. LTD    510(k) NO: K133222(Traditional)
ATTN: RAYMOND J KELLY             PHONE NO : 203 400-7566 
57 LAZY BROOK ROAD                SE DECISION MADE: 06-AUG-14
MONROE CT  06468                  510(k) STATEMENT
                                                    

DEVICE: ZERAMEX T AND ZERAMEX PLUS DENTAL IMPLANT SYSTEMS
DENTALPOINT AG                    510(k) NO: K133255(Traditional)
ATTN: ROSHANA  AHMED              PHONE NO : 905 690 5792 
4 INNOVATION DRIVE                SE DECISION MADE: 12-AUG-14
DUNDAS, ON  CA L9H 7P3            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BLACK NITRILE POWDER FREE EXAM GLOVES
SHANDONG YUANHANG MEDICAL PRODUCTS510(k) NO: K133307(Traditional)
ATTN: RAY  ZHOU                   PHONE NO : 909 548-4828 
12390 EAST END AVE.               SE DECISION MADE: 15-AUG-14
CHINO CA  91710                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR
STERITEC PRODUCTS MFG., CO., INC. 510(k) NO: K133322(Traditional)
ATTN: JONATHAN  RUTIGLIANO        PHONE NO : 303 660-4201 
74 INVERNESS DRIVE EAST           SE DECISION MADE: 25-AUG-14
ENGLEWOOD CO  80112               510(k) STATEMENT
                                                    

DEVICE: BLUE NITRILE POWDER FREE EXAM GLOVES
SHANDONG XINSHI MEDICAL PRODUCTS C510(k) NO: K133325(Traditional)
ATTN: RAY  ZHOU                   PHONE NO : 909 548-4828 
12390 EAST END AVE                SE DECISION MADE: 08-AUG-14
CHINO CA  91710                   510(k) STATEMENT
                                                    

DEVICE: VERITRACT ENTERAL FEEDING TUBE SYSTEM
VERITRACT, INC.                   510(k) NO: K133334(Third Party - Traditional)
ATTN: TIM  NIEMAN                 PHONE NO : 801 891-8610 
383 COLOROW DRIVE                 SE DECISION MADE: 26-AUG-14
SALT LAKE CITY UT  84108          510(k) STATEMENT
                                  THIRD PARTY REVIEW

DEVICE: NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT
NIDEK CO., LTD                    510(k) NO: K133358(Traditional)
ATTN: ENRICO  BISSON              PHONE NO : 39 049 8629200 
VIA DELL'ARTIGIANATO, 6/A         SE DECISION MADE: 12-AUG-14
ALBIGNASEGO  IT 35020             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM
Stryker                           510(k) NO: K133461(Traditional)
ATTN: JULIE  SCHOELL              PHONE NO : 269 389-3419 
750 TRADE CENTRE WAY STE 200      SE DECISION MADE: 01-AUG-14
PORTAGE MI  49002                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ZOLL X SERIES
ZOLL MEDICAL CORP.                510(k) NO: K133484(Traditional)
ATTN: TANMAY  SHUKLA              PHONE NO : 978 421-9171 
269 MILL ROAD                     SE DECISION MADE: 01-AUG-14
CHELMSFORD MA  01824-4105         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NORAS OR HEAD HOLDER "FLEXIBILITY"
NORAS MRI PRODUCTS GMBH           510(k) NO: K133506(Traditional)
ATTN: ZAHED  SEDIGHIANI           PHONE NO : 49 931 29927-17 
LEIBNITZSTRASSE 4                 SE DECISION MADE: 06-AUG-14
HOECHBERG  DE 97204               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ALARIS SYSTEM WITH GUARDRAILS SUITE MX
CAREFUSION 303, INC.              510(k) NO: K133532(Traditional)
ATTN: CHRISTINE  CATON            PHONE NO : 858 617-2990 
10020 PACIFIC MESA BLVD.          SE DECISION MADE: 21-AUG-14
SAN DIEGO CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE VA2, VISERA CYSTO-NE
OLYMPUS CORPORATION OF THE AMERICA510(k) NO: K133538(Traditional)
ATTN: SHERI L MUSGNUNG            PHONE NO : 484 896-3147 
3500 CORPORATE PARKWAY P.O. BOX 61SE DECISION MADE: 07-AUG-14
CENTER VALLEY PA  18034           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: STARLITE-OM, LIGHT EFFECTS, THIBIANT
PS ADVANCED ENGINEERING           510(k) NO: K133546(Traditional)
ATTN: CD  FEAK                    PHONE NO : 626 642-8886 
200 S Garfield Ave Ste 103        SE DECISION MADE: 06-AUG-14
Alhambra CA  91801                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: STERITEC BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR
STERITEC PRODUCTS MFG., CO., INC. 510(k) NO: K133549(Traditional)
ATTN: JONATHAN  RUTIGLIANO        PHONE NO : 303 660-4201 
74 INVERNESS DRIVE EAST           SE DECISION MADE: 27-AUG-14
ENGLEWOOD CO  80112               510(k) STATEMENT
                                                    

DEVICE: CATARHEX 3
OERTLI INSTRUMENTE AG             510(k) NO: K133562(Traditional)
ATTN: KARIN  ROHR                 PHONE NO : 004 171 7474275 
HAFNERWISENSTRASSE 4              SE DECISION MADE: 12-AUG-14
BERNECK  CH 9442                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HEMOSIL D-DIMER HS 500 CONTROL
INSTRUMENTATION LABORATORY        510(k) NO: K133582(Traditional)
ATTN: CAROL  MARBLE               PHONE NO : 781 861-4467 
180 HARTWELL RD                   SE DECISION MADE: 15-AUG-14
BEDFORD MA  01730                 510(k) STATEMENT
                                                    

DEVICE: NEODENT IMPLANT SYSTEM, TITAMAX TI EX ACQUA AND TI DRIVE ACQUA, TITAMAX SMART EX ACQUA AND DRIVE SMART ACQUA, TITAMAX CM
NEODENT USA, INC.                 510(k) NO: K133592(Traditional)
ATTN: CHRISTOPHER  KLACZYK        PHONE NO : 978 747-2575 
60 MINUTEMAN ROAD                 SE DECISION MADE: 22-AUG-14
ANDOVER MA  01810                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GEKO
FIRSTKIND LIMITED                 510(k) NO: K133638(Traditional)
ATTN: SHEILA  HEMEON-HEYER        PHONE NO : 413 549-7463 
231 FAIRBANKS STREET              SE DECISION MADE: 21-AUG-14
WEST BOYLSTON MA  01583           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SLIT LAMP SL-D701
TOPCON CORP.                      510(k) NO: K133667(Traditional)
ATTN: MAUREEN  O'CONNELL          PHONE NO : 978 207-1245 
5 TIMBER LANE                     SE DECISION MADE: 26-AUG-14
NORTH READING MA  01864           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CONFIRM BIOACTIVE
GLOBUS MEDICAL, INC.              510(k) NO: K133678(Traditional)
ATTN: CHRISTINA  KICHULA          PHONE NO : 610 930-1800 2320
2560 General Armistead Ave VALLEY SE DECISION MADE: 26-AUG-14
AUDUBON PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 0.9% SODIUM CHLORIDE FLUSH SYRINGE
AMUSA                             510(k) NO: K133685(Traditional)
ATTN: ALEX  FERRI                 PHONE NO : 615 833-2633 
5209 Linbar Dr Ste 640            SE DECISION MADE: 13-AUG-14
NASHVILLE TN  37211               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TITAN 11
GEMSS MEDICAL SYSTEMS CO., LTD    510(k) NO: K133695(Traditional)
ATTN: DAVE  KIM                   PHONE NO : 713 467-2607 
8310 BUFFALO SPEEDWAY             SE DECISION MADE: 07-AUG-14
HOUSTON TX  77025                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PHYSIOGLOVE ET SYSTEM
COMMWELL R&D LTD.                 510(k) NO: K133703(Traditional)
ATTN: JONATHON  KAHAN             PHONE NO : 202 637-3638 
555 THIRTEENTH STREET NW          SE DECISION MADE: 18-AUG-14
WASHINGTON DC  20004              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ZL MICRODENT NATURAL LOCK IMPLANT SYSTEM
ZL MICRODENT-ATTACHMENT GMBH & CO.510(k) NO: K133706(Traditional)
ATTN: SYNNOVE  LINDEMAN           PHONE NO : 49 2338 80143 
SCHUTZENSTRABE 6-8                SE DECISION MADE: 21-AUG-14
BRECKERFELD  DE D-58339           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MINNCARE HD
MEDIVATORS, INC.                  510(k) NO: K133724(Traditional)
ATTN: KINNARI  SHAH               PHONE NO : 763 553-3369 
14605 28TH AVE. NORTH             SE DECISION MADE: 27-AUG-14
MINNEAPOLIS MN  55447             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ACCU-CHEK Performa Blood Glucose Monitoring System
Roche Diagnostics                 510(k) NO: K133741(Traditional)
ATTN: NATHAN  CARRINGTON          PHONE NO : 317 521-4793 
9115 Hague Road                   SE DECISION MADE: 29-AUG-14
Indianapolis IN  46250            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDS
DIAMOND DIAGNOSTICS, INC          510(k) NO: K133751(Traditional)
ATTN: KATHY  CRUZ                 PHONE NO : 508 429-0450 358
333 Fiske St                      SE DECISION MADE: 08-AUG-14
Holliston MA  01746               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3B RESMART BPAP 25A, BMC RESMART BPAP 25A
3B MEDICAL, INC                   510(k) NO: K133769(Traditional)
ATTN: ALEX  LUCIO                 PHONE NO : 863 226-6285 
21301 HWY 27 N                    SE DECISION MADE: 25-AUG-14
Lake Wales FL  33859              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DIAZYME GLYCATED SERUM PROTEIN POC TEST KIT
DIAZYME LABORATORIES              510(k) NO: K133803(Traditional)
ATTN: Abhijit  Datta              PHONE NO : 857 455-4762 
12889 GREGG COURT                 SE DECISION MADE: 06-AUG-14
POWAY CA  92064                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VITEK 2 AST - YEAST FLUCONAZOLE
BIOMERIEUX, INC.                  510(k) NO: K133817(Traditional)
ATTN: JOCELYN  JENNINGS           PHONE NO : 919 620-2894 
100 RODOLPHE ST                   SE DECISION MADE: 05-AUG-14
DURHAM NC  27712                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) SUSCEPTIBILITY PLATES
Thermo Fisher Scientific          510(k) NO: K133847(Traditional)
ATTN: Cynthia  Knapp              PHONE NO : 800 871-8909 322
1 Thermo Fisher Way               SE DECISION MADE: 01-AUG-14
Oakwood Village OH  44146         510(k) STATEMENT
                                                    

DEVICE: PRECEPTIS TYMPANOSTOMY TUBE INSERTER
PRECEPTIS MEDICAL                 510(k) NO: K133921(Traditional)
ATTN: KEITH  LELAND               PHONE NO : 763 568-7819 
505 HIGHWAY 169 NORTH, #365       SE DECISION MADE: 22-AUG-14
PLYMOUTH MN  55441                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VYNTUS/ SENTRYSUITE PRODUCT LINE
CAREFUSION GERMANY 234 GMBH       510(k) NO: K133925(Traditional)
ATTN: ELMAR  NIEDERMEYER          PHONE NO : 49 931 4972361 
LEIBNIZSTRASSE 7                  SE DECISION MADE: 22-AUG-14
HOECHBERG  DE 97204               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ENDOSCOPE STERILIZATION TRAY
INTUITIVE SURGICAL                510(k) NO: K133942(Abbreviated)
ATTN: BRANDON  HANSEN             PHONE NO : 408 523-7485 
1266 KIFER ROAD                   SE DECISION MADE: 01-AUG-14
SUNNYVALE CA  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CUTERA PICOSECOND LASER SYSTEM
CUTERA, INC.                      510(k) NO: K133945(Traditional)
ATTN: BRADLEY  RENTON             PHONE NO : 415 657-5568 
3240 BAYSHORE BLVD                SE DECISION MADE: 11-AUG-14
BRISBANE CA  94005                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VITEK 2 AST YS FLUCYTOSINE, VITEK 2 AST YEAST FLUCYTOSINE
BIOMERIEUX, INC.                  510(k) NO: K133952(Traditional)
ATTN: CHARLENE  FERRAND           PHONE NO : 314 731-8630 
595 ANGLUM RD.                    SE DECISION MADE: 19-AUG-14
HAZELWOOD MO  63042               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TEMPUS PRO WITH ENHANCED FEATURES
REMOTE DIAGNOSTIC TECHNOLOGIES LTD510(k) NO: K133973(Abbreviated)
ATTN: LEIGH  CORNOCK              PHONE NO : 44 1256 362409 
THE OLD COACH HOUSE, THE AVENUE, FSE DECISION MADE: 14-AUG-14
BASINGSTOKE  GB RG252HT           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TENS
SUNMAS (H.K.) TRADING LIMITED     510(k) NO: K133979(Traditional)
ATTN: Diana  Hong                 PHONE NO : 86 21 22815850 
PO BOX 237-023                    SE DECISION MADE: 26-AUG-14
SHANGHAI  CN 200237               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AVACEN 100
AVACEN INC.                       510(k) NO: K133981(Abbreviated)
ATTN: THOMAS G MUEHLABUER         PHONE NO : 888 428-2236 708
7920 SILVERTON AVENUE SUITE L     SE DECISION MADE: 15-AUG-14
SAN DIEGO CA  92126               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ISY
ALTATEC GMBH                      510(k) NO: K133991(Traditional)
ATTN: LINDA  SCHULZ               PHONE NO : 858 792-1235 
12264 EL CAMINO REAL SUITE 400    SE DECISION MADE: 06-AUG-14
SAN DIEGO CA  92130               510(k) STATEMENT
                                                    

DEVICE: TEMPUS PRO ACCESSORIES (ULTRASOUND & VIDEO LARYNGOSCOPE PROBE)
REMOTE DIAGNOSTIC TECHNOLOGIES LTD510(k) NO: K134014(Traditional)
ATTN: LEIGH  CORNOCK              PHONE NO : 44 1256 362409 
THE OLD COACH HOUSE, THE AV. FARLESE DECISION MADE: 12-AUG-14
HAMPSHIRE  GB RG25 2HT            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PREMVIA
BIOTIME, INC.                     510(k) NO: K134037(Traditional)
ATTN: DAVID C FURR                PHONE NO : 512 906-9654 
8708 CAPEHART COVE                SE DECISION MADE: 07-AUG-14
AUSTIN TX  78733                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SOPRANO ICE MULTI-APPLICATION & MULTI-TECHNOLOGY PLATFORM
ALMA LASERS LTD.                  510(k) NO: K140009(Traditional)
ATTN: KATHY  MAYNOR               PHONE NO : 352 586-3113 
26 REBECCA CT                     SE DECISION MADE: 29-AUG-14
HOMOSASSA FL  34446               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GALT VTI LOW INSERTION VALVE TEARAWAY INTRODUCER
GALT MEDICAL CORP.                510(k) NO: K140028(Traditional)
ATTN: DAVID  DERRICK              PHONE NO : 972 271-5177 
2220 MERRITT DR.                  SE DECISION MADE: 21-AUG-14
GARLAND TX  75041                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PERSONAL KINETIGRAPH (PKG) SYSTEM
GKC MANUFACTURING PTY LTD.        510(k) NO: K140086(Traditional)
ATTN: MARIE  SCHROEDER            PHONE NO : 301 272-3286 
1801 ROCKVILLE PIKE SUITE 300     SE DECISION MADE: 22-AUG-14
ROCKVILLE MD  20852               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PRO PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM
NIPRO DIAGNOSTICS, INC.           510(k) NO: K140100(Traditional)
ATTN: BETH  FOSTER                PHONE NO : 954 677-9201 3044
2400 NW 55TH COURT                SE DECISION MADE: 01-AUG-14
Fort Lauderdale FL  33309         510(k) STATEMENT
                                                    

DEVICE: EPX-4440HD DIGITAL VIDEO PROCESSOR
FUJIFILM MEDICAL SYSTEMS U.S.A., I510(k) NO: K140149(Traditional)
ATTN: MARY K MOORE                PHONE NO : 800 385-4666 
10 HIGH POINT DR                  SE DECISION MADE: 22-AUG-14
WAYNE NJ  07470                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EASYSTIM TN28_OTC
EASYMED INSTRUMENTS CO., LTD.     510(k) NO: K140168(Traditional)
ATTN: JEFFERY  WU                 PHONE NO : 86 757 28091300 
5/F- 6/F, Block A, Gupo Gongmao BuSE DECISION MADE: 28-AUG-14
Daliang, Shunde, Foshan  CN 528300510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: INTRAVASCULAR ADMINISTRATION SET
DELTA MED SPA                     510(k) NO: K140175(Traditional)
ATTN: ROGER  GRAY                 PHONE NO : 39 06 5782665 
PIAZZA ALBANIA, N'10              SE DECISION MADE: 05-AUG-14
ROME  IT 00153                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JWX-2
YAMAHA MOTOR CO., LTD.            510(k) NO: K140204(Third Party - Traditional)
ATTN: MASANORI  YONEMITSU         PHONE NO : 81 53 4606167 
882 SOUDE, NAKA-KU                SE DECISION MADE: 28-AUG-14
HAMAMATSU, SHIZUOKA  JP 435-0054  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM ( GM720, RIGHTEST PROFESSIONAL BGMS GM720
BIONIME CORPORATION               510(k) NO: K140210(Traditional)
ATTN: Feng-Yu  Lee                PHONE NO : 949 951-3046 
29222 RANCHO VIEJO ROAD SUITE 218 SE DECISION MADE: 22-AUG-14
SAN JUN CAPISTRANO CA  92675      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SYNGO CT 2014A (SOMARIS/5 VB42) FOR SOMATOM EMOTION & SENSATION FAMILY CT
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K140232(Traditional)
ATTN: EVE  DAVIS                  PHONE NO : 610 279-7133 
51 VALLEY STREAM PKWY.            SE DECISION MADE: 14-AUG-14
MALVERN PA  19355-1406            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NEXUS MIDLINE CT CATHETER
HEALTH LINE INTERNATIONAL CORPORAT510(k) NO: K140270(Traditional)
ATTN: JOHN E LINCOLN              PHONE NO : 435 841-0252 
PO BOX 2786                       SE DECISION MADE: 20-AUG-14
ST. GEORGE UT  84771-2786         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CAYA CONTOURED DIAPHRAGM
KESSEL MEDINTIM GMBH              510(k) NO: K140305(Traditional)
ATTN: KESSEL  MARKETING           PHONE NO : 49 6105 203728 
KELSTERBACHER STR. 28 MOERFELDEN WSE DECISION MADE: 26-AUG-14
FRANKFURT  DE 64546               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CORMATRIX PROTECT ECM ENVELOPE
CORMATRIX CARDIOVASCULAR, INC.    510(k) NO: K140306(Traditional)
ATTN: BRYAN  BROSSEAU             PHONE NO : 678 566-2628 
1100 OLD ELLIS ROAD               SE DECISION MADE: 15-AUG-14
ROSWELL GA  30076                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MASTERSURG / EXPERTSURG
KALTENBACH & VOIGT GMBH           510(k) NO: K140308(Traditional)
ATTN: STEFAN  TRAMPLER            PHONE NO : 49 735 1563515 
BISMARCKRING 39                   SE DECISION MADE: 15-AUG-14
BIBERACH  DE 88400                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3M STERI-DRAPE FABRIC SURGICAL DRAPES
3M HEALTH CARE                    510(k) NO: K140330(Traditional)
ATTN: MARK  BURVILLE              PHONE NO : 651 737-2027 
BUILDING 275-5W-06                SE DECISION MADE: 18-AUG-14
ST PAUL MN  55144-1000            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CREGANNA TACTX LOTUS INTRODUCER SET (SMALL), CREGANNA TACTX LOTUS INTRODUCER SET (LARGE)
CREGANNA-TACTX MEDICAL            510(k) NO: K140338(Traditional)
ATTN: NIALL  FOX                  PHONE NO : 353 91 769301 
PARKMORE WEST                     SE DECISION MADE: 27-AUG-14
GALWAY  IE IRELAND                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: QCT PRO ASYNCHRONOUS CALIBRATION MODULE, CLINIQCT
MINDWAYS SOFTWARE, INC.           510(k) NO: K140342(Traditional)
ATTN: KEENAN  BROWN               PHONE NO : 512 912-0871 
3001 S Lamar Blvd Ste 302         SE DECISION MADE: 29-AUG-14
AUSTIN TX  78704                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ANKYLOS C/X IMPLANT SYSTEM
DENTSPLY INTL., INC.              510(k) NO: K140347(Traditional)
ATTN: HELEN  LEWIS                PHONE NO : 717 487-1332 
221 WEST PHILADELPHIA STREET SUITESE DECISION MADE: 20-AUG-14
YORK PA  17404                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ENDLESSFIBER REUSABLE SURGICAL LASER FIBER
HOGUE SURGICAL LLC                510(k) NO: K140366(Traditional)
ATTN: ROGER S HOGUE, MD           PHONE NO : 763 424-8682 
7365 KIRKWOOD CT. N., STE 350     SE DECISION MADE: 15-AUG-14
MAPLE GROVE MN  55369             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SENSILIGHT/ SENSILIGHT PLUS
EL GLOBAL TRADE LTD.              510(k) NO: K140381(Traditional)
ATTN: SHLOMIT  SEGMAN             PHONE NO : 972 9788 9069 
TZORAN 4TH ST.                    SE DECISION MADE: 08-AUG-14
NETANYA  IL 42504                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3M ATTEST RAPID READOUT BIOLOGICAL INDICATOR / 3M ATTEST AUTO-READER
3M COMPANY                        510(k) NO: K140392(Traditional)
ATTN: SUZANNE  LEUNG              PHONE NO : 651 575-8052 
3M CENTER, BLDG. 275-5W-06        SE DECISION MADE: 13-AUG-14
ST. PAUL MN  55144-1000           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DIOTECH LASER FIBER
DIOTECH CO                        510(k) NO: K140458(Traditional)
ATTN: PETER  CHUNG                PHONE NO : 412 687-3976 
300 ATWOOD STREET                 SE DECISION MADE: 26-AUG-14
PITTSBURGH PA  15213              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARTHREX FIBERTAK SUTURE ANCHOR
ARTHREX, INC.                     510(k) NO: K140476(Traditional)
ATTN: COURTNEY  SMITH             PHONE NO : 239 643-5553 1720
1370 CREEKSIDE BLVD.              SE DECISION MADE: 13-AUG-14
NAPLES FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AEQUALIS REVERSED SHOULDER PROSTHESIS
Tornier SAS                       510(k) NO: K140478(Traditional)
ATTN: MAGALIE  HENNEQUIN          PHONE NO : 33 4 76613500 
161 RUE LAVOISIER                 SE DECISION MADE: 06-AUG-14
MONTBONNOT SAINT MARTIN  FR 38330 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CIVA SHEET PD-103
CIVATECH ONCOLOGY, INC.           510(k) NO: K140490(Traditional)
ATTN: BLIX  WINSTON               PHONE NO : 301 607-9185 
2600 MULLINIX MILL ROAD           SE DECISION MADE: 29-AUG-14
MT. AIRY MD  21771                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HIOSSEN PROSTHETIC SYSTEM
OSSTEM IMPLANT CO., LTD.          510(k) NO: K140507(Traditional)
ATTN: PATRICK  LIM                PHONE NO : 888 678-0001 
85 BEN FAIRLESS DR.               SE DECISION MADE: 20-AUG-14
FAIRLESS HILLS PA  19030          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ZIMMER PLATES AND SCREWS SYSTEM(ZPS)- NON-STERILE PLATES AND SCREWS
ZIMMER, INC.                      510(k) NO: K140508(Traditional)
ATTN: STEPHEN H MCKELVEY, MA, RAC PHONE NO : 574 372-4944 
P.O. BOX 708                      SE DECISION MADE: 14-AUG-14
WARSAW IN  46581-0708             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Terumo Pen Injector Needle 34
KOFU FACTORY OF TERUMO CORP.      510(k) NO: K140516(Traditional)
ATTN: PHILLIP  LESTER             PHONE NO : 410 392-7321 
950 ELKTON BLVD                   SE DECISION MADE: 05-AUG-14
ELKTON MD  21921                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TENURE4G
DEN-MAT HOLDINGS, LLC             510(k) NO: K140537(Traditional)
ATTN: HELEN  RAGUS                PHONE NO : 805 346-3700 2932
1017 W Central Ave                SE DECISION MADE: 20-AUG-14
Lompoc CA  93436                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ORTHOHUB EXTERNAL FIXATOR SOFTWARE
ORTHOHUB, INC.                    510(k) NO: K140550(Traditional)
ATTN: PEGGY  MCLAUGHLIN           PHONE NO : 650 504-8501 
999 MENLO OAKS DRIVE              SE DECISION MADE: 25-AUG-14
MENLO PARK CA  94025              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PERKINELMER, XRPAD 4336 MED FLAT PANEL DETECTOR
PERKINELMER, INC.                 510(k) NO: K140551(Traditional)
ATTN: DAWN  SPOONER               PHONE NO : 781 663-6071 
940 WINTER STREET                 SE DECISION MADE: 01-AUG-14
WALTHAM MA  02451                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LATERAL VBR SYSTEM
NUVASIVE, INCORPORATED            510(k) NO: K140563(Traditional)
ATTN: JEREMY  MARKOVICH           PHONE NO : 858 309-3783 
7475 LUSK BLVD                    SE DECISION MADE: 07-AUG-14
SAN DIEGO CA  92121               510(k) STATEMENT
                                                    

DEVICE: FINGERTIP PULSE OXIMETER
SHENZHEN JUMPER MEDICAL EQUIPMENT 510(k) NO: K140582(Traditional)
ATTN: FIELD  FU                   PHONE NO : 86 755 86069197 
4TH FLOOR, JINHUI BUILDING, NANHAISE DECISION MADE: 28-AUG-14
SHENZHEN, GUANGDONG  CN 518000    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CTC TCAT(R)-TPLAN(R) SURGICAL SYSTEM
CUREXO TECHNOLOGY CORPORATION     510(k) NO: K140585(Traditional)
ATTN: GLEN  EMELOCK               PHONE NO : 781 665-9893 
32 HARRISON ST.                   SE DECISION MADE: 18-AUG-14
MELROSE MA  02176                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SB ANCHOR
OSSTEM IMPLANT CO., LTD.          510(k) NO: K140600(Traditional)
ATTN: PATRICK  LIM                PHONE NO : 888 678-0001 
85 BEN FAIRLESS DR.               SE DECISION MADE: 21-AUG-14
FAIRLESS HILLS PA  19030          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SPORVIEW PLUS BI TEST PACK
CROSSTEX INTERNATIONAL            510(k) NO: K140620(Traditional)
ATTN: MICHAEL G NOLAN             PHONE NO : 585 359-0130 
6789 WEST HENRIETTA ROAD          SE DECISION MADE: 07-AUG-14
RUSH NY  14543                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BELTER INFRA-RED EAR THERMOMETER
SHENZHEN BELTER HEALTH MEASUREMENT510(k) NO: K140681(Traditional)
ATTN: PANG  MING                  PHONE NO : 867 55 61869839 
702, 704 BLOCK C, TSINGHUA UNIS SCSE DECISION MADE: 21-AUG-14
SHENZHEN, GUANGDONG  CN 518057    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HEVYLITE HUMAN IGM KAPPA AND LAMBDA KIT FOR USE ON SPAPLUS
THE BINDING SITE GROUP LTD        510(k) NO: K140686(Traditional)
ATTN: SUZANNE  HORNE              PHONE NO : 44 121456 9500 
8 CALTHORPE ROAD EDGBASTON        SE DECISION MADE: 06-AUG-14
BIRMINGHAM, WEST MIDLANDS  GB B15 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IKNEE DISTAL FEMORAL CUTTING GUIDE
EVERGREEN ORTHOPEDIC RESEARCH LAB 510(k) NO: K140689(Traditional)
ATTN: JEFF  STEPANIAN             PHONE NO : 425 284-7262 
11321 NE 120TH ST                 SE DECISION MADE: 22-AUG-14
KIRKLAND WA  98034                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OPA 30 SOLUTION
CIDEN TECHNOLOGIES LLC            510(k) NO: K140703(Traditional)
ATTN: COURTNEY  CLARK             PHONE NO : 714 516-7426 
1717 W. COLLINS AVE.              SE DECISION MADE: 19-AUG-14
ORANGE CA  92867                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NOMAD MD 75K V HANDHELD X-RAY SYSTEM
ARIBEX, INC.                      510(k) NO: K140723(Traditional)
ATTN: CHRISTOPHER  DODGE          PHONE NO : 801 226-5522 
744 SOUTH 400 EAST                SE DECISION MADE: 19-AUG-14
Orem UT  84097                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EVOLUTION MP CS/CR POROUS FEMUR/EVOLUTION ADAPTIVE CS AND PS INSERTS
MICROPORT ORTHOPEDICS INC.        510(k) NO: K140735(Traditional)
ATTN: CAROLINE  FRYAR             PHONE NO : 901 290-5100 
5677 AIRLINE RD                   SE DECISION MADE: 29-AUG-14
ARLINGTON TN  38002               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: STRAUMANN CARES SCREW RETAINED BARS/BRIDGE
STRAUMANN USA, LLC                510(k) NO: K140737(Traditional)
ATTN: CHRISTOPHER  KLACZYK        PHONE NO : 978 747-2575 
60 MINUTEMAN ROAD                 SE DECISION MADE: 14-AUG-14
ANDOVER MA  01810                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ONE STEP SINGLE/MULTI-DRUG TEST CUP, ONE STEP SINGLE/MULTI-DRUG TEST DIPCARD
CO-INNOVATION BIOTECH CO.,LTD.    510(k) NO: K140748(Traditional)
ATTN: HONG  FENG                  PHONE NO : 862 062867 285 
No.13, Yanyuan Road, Tianhe DistriSE DECISION MADE: 20-AUG-14
Guangzhou  CN 510507              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ULTRAMIST SYSTEM, ULTRAMIST GENERATOR, ULTRAMIST TREATMENT WAND, ULTRAMIST APPLICATOR
CELLERATION, INC.                 510(k) NO: K140782(Traditional)
ATTN: KATHY  SIMPSON              PHONE NO : 952 224-8700 
6321 BURY DRIVE, STE 15           SE DECISION MADE: 13-AUG-14
EDEN PRAIRIE MN  55346            510(k) STATEMENT
                                                    

DEVICE: MI-750 PROCEDURAL/MINOR SURGICAL LIGHT
MEDICAL ILLUMINATION INTERNATIONAL510(k) NO: K140812(Traditional)
ATTN: ROBERT  HESS                PHONE NO : 818 838-3025 
547 LIBRARY ST.                   SE DECISION MADE: 07-AUG-14
SAN FERNANDO CA  91340            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GENESIS REUSABLE RIGID CONTAINER SYSTEM
CAREFUSION 2200, INC.             510(k) NO: K140850(Traditional)
ATTN: JANE  WEBER                 PHONE NO : 847 362-8094 
75 N. FAIRWAY DR.                 SE DECISION MADE: 27-AUG-14
VERNON HILLS IL  60061            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MONICA NOVII WIRELESS PATCH SYSTEM
MONICA HEALTHCARE LTD.            510(k) NO: K140862(Traditional)
ATTN: CARL  BARRATT               PHONE NO : 44 115 9124540 
BIOCITY, PENNYFOOT STREET         SE DECISION MADE: 27-AUG-14
NOTTINGHAM  GB NG1 1GF            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: STRAUMANN BONE LEVEL TAPERED IMPLANT
STRAUMANN USA, LLC                510(k) NO: K140878(Traditional)
ATTN: CHRISTOPHER  KLACZYK        PHONE NO : 978 747-2575 
60 MINUTEMAN ROAD                 SE DECISION MADE: 20-AUG-14
ANDOVER MA  01810                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DEVILBISS SMARTLINK II SYSTEM
DEVILBISS HEALTHCARE LLC          510(k) NO: K140880(Traditional)
ATTN: BETTY  MILLER               PHONE NO : 814 443-7602 
100 DEVILBISS HEALTHCARE          SE DECISION MADE: 04-AUG-14
SOMERSET PA  15501                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: WALKAIDE SYSTEM
INNOVATIVE NEUROTRONICS INC.      510(k) NO: K140886(Traditional)
ATTN: GLEN  NEALLY                PHONE NO : 512 721-1903 
3600-B N. CAPITAL OF TEXAS HWY BLDSE DECISION MADE: 08-AUG-14
AUSTIN TX  78746-3211             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DISTAL ELBOW PLATING SYSTEM
SKELETAL DYNAMICS, LLC            510(k) NO: K140892(Traditional)
ATTN: ANA M ESCAGEDO              PHONE NO : 305 596-7585 
8905 SW 87 AVENUE, SUITE 201      SE DECISION MADE: 28-AUG-14
MIAMI FL  33176                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VAPR ARCTIC SUCTION ELECTRODE
DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K140896(Traditional)
ATTN: SUSAN  KAGAN                PHONE NO : 508 880-8097 
325 PARAMOUNT DR.                 SE DECISION MADE: 05-AUG-14
RAYNHAM MA  02767                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RESPICONNECT ADAPTER
TRUDELL MEDICAL INT'L             510(k) NO: K140919(Traditional)
ATTN: DARRYL  FISCHER             PHONE NO : 519 455 7060 
725 THIRD ST.                     SE DECISION MADE: 15-AUG-14
LONDON, ONTARIO  CA N5V 5G4       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ALIVECOR HEART MONITOR
ALIVECOR, INC.                    510(k) NO: K140933(Traditional)
ATTN: Albert  Boniske             PHONE NO : 415 795-9811 
30 MAIDEN LANE, 6TH FLOOR         SE DECISION MADE: 15-AUG-14
SAN FRANCISCO CA  94108           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 1.8 MM PHOENIX ATHERECTOMY CATHETER, 2.2 MM PHOENIX ATHERECTOMY CATHETER, PHOENIX HANDLE, PHOENIX WIRE SUPPORT CLIP
ATHEROMED INC                     510(k) NO: K140944(Special)
ATTN: JEAN  CHANG                 PHONE NO : 650 473-6846 
1455 ADAMS DRIVE SUITE 1120       SE DECISION MADE: 22-AUG-14
MENLO PARK CA  94025              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: COMPACTCATH INTERMITTENT URINARY CATHETER
COMPACTCATH INC                   510(k) NO: K140945(Traditional)
ATTN: GREGORY  MATHISON           PHONE NO : 218 387-1559 
3924 CASCADE BEACH ROAD           SE DECISION MADE: 22-AUG-14
LUTSEN MN  55612                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NOVABONE MACROFORM BIOACTIVE PACKABLE, NOVABONE MACROFORM BIOACTIVE COMPOSITE
NovaBone Products, LLC            510(k) NO: K140946(Traditional)
ATTN: Lisa  Simpson               PHONE NO : 389 462-7661 216
13510 NW US Highway 441           SE DECISION MADE: 22-AUG-14
Alachua FL  32615                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GENTLECATH MALE COUDE OLIVE TIP INTERMITTENT URINARY CATHETER
CONVATEC LTD.                     510(k) NO: K140953(Traditional)
ATTN: CLARE  WILLIAMSON           PHONE NO : 004 401244 584155 
UNIT 20, FIRST AVENUE, DEESIDE INDSE DECISION MADE: 01-AUG-14
DEESIDE  GB CH5 2NU               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LCD MONITOR
NORDICNEUROLAB                    510(k) NO: K140956(Traditional)
ATTN: CHANDANA G BHANDARI         PHONE NO : 475 570 7095 
MOLLENDALSVEIEN 65C               SE DECISION MADE: 07-AUG-14
BERGEN, HORDALAND  NO 5009        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MULTIPIEZO PRO, MULTIPIEZO
MECTRON SPA                       510(k) NO: K140965(Traditional)
ATTN: ROGER  GRAY                 PHONE NO : 39 06 5782665 
PIAZZA ALBANIA, 10                SE DECISION MADE: 20-AUG-14
ROME  IT 00153                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VONFLEX S BITE
VERICOM CO., LTD.                 510(k) NO: K140966(Traditional)
ATTN: Myung-Hwan  Oh              PHONE NO : 714 5089462 
48, Toegyegongdan 1-gil           SE DECISION MADE: 15-AUG-14
Chuncheon-Si, Gangwon - Do  KR 200510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: POWDER FREE STERILE LATEX SURGICAL GLOVE, YELLOW COLOR (BRAND NAME: TITANFINE)
HEBEI HONGSEN PLASTICS TECHNOLOGY 510(k) NO: K140988(Traditional)
ATTN: CHARLES  SHEN               PHONE NO : 608 217-9358 
853 DORCHESTER LN, UNITB          SE DECISION MADE: 12-AUG-14
NEW MILFORD NJ  07646             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TANDEMHEART VENO-VENOUS CANNULA
CARDIACASSIST INC.                510(k) NO: K140999(Traditional)
ATTN: Greg  Johnson               PHONE NO : 412 963-7770 
240 ALPHA DRIVE                   SE DECISION MADE: 06-AUG-14
PITTSBURGH PA  15238              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: INTRAOSSEOUS FIXATION SYSTEM
ORTHOHELIX SURGICAL DESIGNS, INC. 510(k) NO: K141004(Special)
ATTN: BRIAN  HOCKETT              PHONE NO : 330 869-9562 
1065 Medina Rd. SUITE 500         SE DECISION MADE: 21-AUG-14
Medina OH  44256                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Z-LINK CERVICAL
ZAVATION, LLC                     510(k) NO: K141005(Traditional)
ATTN: JOHN  WALKER                PHONE NO : 601 919-1119 
400 LIBERTY PARK                  SE DECISION MADE: 07-AUG-14
FLOWOOD MS  39232                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HYDROCLEANSE WOUND CARE SOLUTION
OCULUS INNOVATIVE SCIENCES        510(k) NO: K141012(Traditional)
ATTN: BRIAN W MARTIN              PHONE NO : 707 283-0550 
1129 N MCDOWELL BLVD              SE DECISION MADE: 08-AUG-14
PETALUMA CA  94954                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: POWDER-FREE NITRILE EXAMINATION GLOVES, ORANGE, COLOR
HL RUBBER INDUSTRIES SDN BHD      510(k) NO: K141021(Traditional)
ATTN: NOORZALIZA  AHMAD           PHONE NO : 606 481108 788 
LOT 10, KAWASAN PERINDUSTRIAN DIOHSE DECISION MADE: 26-AUG-14
KUALA PILAH, NEGERI SEMBILAN  MY 7510(k) STATEMENT
                                                    

DEVICE: M.U.S.T. EXTENSION
MEDACTA INTERNATIONAL             510(k) NO: K141044(Traditional)
ATTN: ADAM  GROSS                 PHONE NO : 805 910-6511 
1556 W. CARROLL AVENUE            SE DECISION MADE: 18-AUG-14
CHICAGO IL  60607                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTS
STRYKER ORTHOPAEDICS              510(k) NO: K141056(Traditional)
ATTN: KAREN  ARIEMMA              PHONE NO : 201 831-5718 
325 Corporate Drive               SE DECISION MADE: 05-AUG-14
Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ENSIZOR ENDOSCOPIC SCISSORS
SLATER ENDOSCOPY, LLC             510(k) NO: K141058(Traditional)
ATTN: CRAIG  PAGAN                PHONE NO : 321 728-0125 102
1135 W NASA BLVD. SUITE 500       SE DECISION MADE: 01-AUG-14
MELBOURNE FL  32901               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NATURAL RUBBER LATEX MALE CONDOMS
KAREX INDUSTRIES SDN BHD          510(k) NO: K141059(Abbreviated)
ATTN: MARY  GOH                   PHONE NO : 607 688 1996 
PTD. 7906/7907, TAMAN PONTIAN JAYASE DECISION MADE: 01-AUG-14
PONTIAN, JOHOR  MY 82000          510(k) STATEMENT
                                                    

DEVICE: REMOTEYE VIEWER
NEOLOGICA S.R.L.                  510(k) NO: K141061(Traditional)
ATTN: MARCO  SAMBIN               PHONE NO : 39 019 505314 
STRADA VILLE, 58 - 17014          SE DECISION MADE: 01-AUG-14
CAIRO MONTENOTTE (SV)  IT IT      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CONSTELLATION VISION SYSTEM
ALCON RESEARCH, LTD.              510(k) NO: K141065(Traditional)
ATTN: ROBERT  LUNDBERG            PHONE NO : 949 505-7817 
20511 Lake Forest Dr              SE DECISION MADE: 22-AUG-14
Lake Forest CA  92630             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DA VINCI FIREFLY IMAGING SYSTEM
INTUITIVE SURGICAL, INC.          510(k) NO: K141077(Traditional)
ATTN: MELISSA S GONZALEZ          PHONE NO : 408 523-2100 
1266 KIFER RD                     SE DECISION MADE: 12-AUG-14
SUNNYVALE CA  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR
MICROLIFE INTELLECTUAL PROPERTY GM510(k) NO: K141083(Special)
ATTN: SUSAN D GOLDSTEIN-FALK      PHONE NO : 949 706-7456 
55 NORTHERN BOULEVARD SUITE 200   SE DECISION MADE: 22-AUG-14
GREAT NECK NY  10021              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NC EUPHORA RAPID EXCHANGE BALLOON DILATATION CATHETER
MEDTRONIC INC.                    510(k) NO: K141090(Traditional)
ATTN: JOHN  KILMARTIN             PHONE NO : 353 91 708161 
PARKMORE BUSINESS PARK WEST       SE DECISION MADE: 15-AUG-14
GALWAY  IE IRELAND                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: STRYKER STERI-SHIELD FLYTE HYBRID TOGAS
STRYKER CORPORATION               510(k) NO: K141095(Special)
ATTN: JULIA  HELGESON             PHONE NO : 269 389-4789 
4100 E. MILHAM AVE                SE DECISION MADE: 26-AUG-14
KALAMAZOO MI  49001               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LITHO
QUANTA SYSTEM, S.P.A.             510(k) NO: K141101(Special)
ATTN: Maurizio  Bianchi           PHONE NO : 390 331 376797 
VIA IV NOVEMBRE,116               SE DECISION MADE: 08-AUG-14
SOLBIATE OLONA  IT 21058          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MEDLINE ANTI-EMBOLISM STOCKING
MEDLINE INDUSTRIES, INC.          510(k) NO: K141127(Traditional)
ATTN: MATT  CLAUSEN               PHONE NO : 847 643-4785 
ONE MEDLINE PLACE                 SE DECISION MADE: 21-AUG-14
MUNDELEIN IL  60060               510(k) STATEMENT
                                                    

DEVICE: FINGERTIP PULSE OXIMETER
BEIJING CHOICE ELECTRONIC TECHNOLO510(k) NO: K141128(Traditional)
ATTN: LEI  CHEN                   PHONE NO : 861 088798 300X6020 
NO. 9 SHUANGYUAN ROAD, BADACHU HI-SE DECISION MADE: 13-AUG-14
BEIJING  CN 100041                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EXACTECH CERVICAL SPACER SYSTEM
EXACTECH, INC.                    510(k) NO: K141129(Traditional)
ATTN: MEREDITH  MAY MS, RAC       PHONE NO : 719 337-7579 
4628 NORTHPARK DRIVE              SE DECISION MADE: 15-AUG-14
COLORADO SPRINGS CO  80918        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LEICA FL800
LEICA BIOSYSTEMS RICHMOND         510(k) NO: K141136(Traditional)
ATTN: BARBARA-ANN  CONWAY-MYERS   PHONE NO : 312 259-7205 
5205 RT 12                        SE DECISION MADE: 19-AUG-14
SOLON MILLS IL  60071             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KIVA VCF TREATMENT SYSTEM
BENVENUE MEDICAL, INC.            510(k) NO: K141141(Traditional)
ATTN: CINDY  DOMECUS, R.A.C.      PHONE NO : 650 343-4813 
1171 BARROILHET DR.               SE DECISION MADE: 14-AUG-14
HILLSBOROUGH CA  94010            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ALL-CERAMIC ZIRCONIA BLOCK
RIZHAO HUGE DENTAL INDUSTRY CO., L510(k) NO: K141162(Abbreviated)
ATTN: HELEN  NAN                  PHONE NO : 086 577886 06182 
ROOM 302, NO. 21 BLDG, KAIYU GARDESE DECISION MADE: 27-AUG-14
WENZHOU, ZHEJIANG  CN 325000      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES, ONCOZENE MICROSPHERES
CELONOVA BIOSCIENCES, INC.        510(k) NO: K141209(Traditional)
ATTN: NICOLE  BARBER              PHONE NO : 210 497-6682 
18615 Tuscany Stone Ste 100       SE DECISION MADE: 07-AUG-14
San Antonio TX  78258             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SURGISEAL TWIST TOPICAL SKIN ADHESIVE
Adhezion Biomedical, LLC          510(k) NO: K141215(Traditional)
ATTN: RICHARD  JONES              PHONE NO : 610 241-7191 
ONE MERIDIAN BOULEVARD SUITE 1B02 SE DECISION MADE: 21-AUG-14
WYOMISSING PA  19610              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ESG-400, FOOTSWITCH DOUBLE PEDAL, FOOTSWITCH SINGLE PEDAL, P-CORD
OLYMPUS WINTER & IBE GMBH         510(k) NO: K141225(Traditional)
ATTN: GRAHAM A L BAILLIE          PHONE NO : 508 804-2738 
136 TURNPIKE RD.                  SE DECISION MADE: 12-AUG-14
SOUTHBOROUGH MA  01772            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DOSELAB PRO
MOBIUS MEDICAL SYSTEMS, LP        510(k) NO: K141230(Traditional)
ATTN: STAN  ESHELMAN              PHONE NO : 888 263-8541 
5012 TAMARISK ST.                 SE DECISION MADE: 27-AUG-14
BELLAIRE TX  77401                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NC EMERGE PTCA DILATATION CATHETER (MONORAIL), NC EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE)
Boston Scientific Corporation     510(k) NO: K141236(Traditional)
ATTN: ADRIENNE  HOTCHKISS         PHONE NO : 763 494-1588 
ONE SCIMED PLACE                  SE DECISION MADE: 07-AUG-14
MAPLE GROVE MN  55311             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LITONG POWDER-FREE YELLOW VINYL PATIENT EXAMINATION GLOVES
ZIBO LITONG PLASTIC PRODUCTS CO., 510(k) NO: K141239(Traditional)
ATTN: CHU  XIAOAN                 PHONE NO : 861 082 387441 
ROOM 1606 BLDG 1, JIANXIANG YUAN NSE DECISION MADE: 27-AUG-14
BEIJING, HAIDIAN DISTRICT  CN 1000510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MATRIXRIB ENDO THORACOSCOPIC RIB PLATING SYSTEM
SYNTHES (USA) PRODUCTS LLC        510(k) NO: K141241(Traditional)
ATTN: SUSAN  LEWANDOWSKI          PHONE NO : 610 719-5852 
1302 WRIGHTS LANE EAST            SE DECISION MADE: 07-AUG-14
WEST CHESTER PA  19380            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TENSYN BAND, TENSYN FRACTURE PLATES
DALLEN MEDICAL, INC.              510(k) NO: K141264(Traditional)
ATTN: AL  MEMMOLO                 PHONE NO : 949 218-0030 
1046 Calle Recodo Ste G           SE DECISION MADE: 21-AUG-14
San Clemente CA  92673            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CRIT-LINE CLIP (CLIC) BLOOD CHAMBER
FRESENIUS MEDICAL CARE RENAL THERA510(k) NO: K141281(Traditional)
ATTN: DENISE  OPPERMANN           PHONE NO : 781 699-4479 
920 Winter Street                 SE DECISION MADE: 14-AUG-14
Waltham MA  02451                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ECLIPSE TREATMENT PLANNING SYSTEM
VARIAN MEDICAL SYSTEMS, INC.      510(k) NO: K141283(Traditional)
ATTN: PETER J CORONADO            PHONE NO : 650 424-6320 
911 HANSEN WAY                    SE DECISION MADE: 07-AUG-14
PALO ALTO CA  94303               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VOYANT ELECTROSURGICAL GENERATOR, VOYANT 5MM LAPAROSCOPIC SEALER-DIVIDER DEVICE
APPLIED MEDICAL RESOURCES         510(k) NO: K141288(Traditional)
ATTN: JESSICA  CHO                PHONE NO : 949 713-7958 
22872 Avenida Empresa             SE DECISION MADE: 22-AUG-14
Rancho Santa Margarita CA  92688  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VERTIFORM POSTERIOR FIXATION SYSTEM
NEXT ORTHOSURGICAL                510(k) NO: K141291(Traditional)
ATTN: HUAN  TRAN                  PHONE NO : 858 790-9349 
3270 Corporate Vw Ste A           SE DECISION MADE: 26-AUG-14
Vista CA  92081                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: U BY KOTEX SECURITY UNSCENTED MENSTRUAL TAMPONS
KIMBERLY-CLARK CORP.              510(k) NO: K141294(Traditional)
ATTN: CHARNELLE  THOMAS           PHONE NO : 678 352-6031 
1400 HOLCOMB BRIDGE RD.           SE DECISION MADE: 25-AUG-14
ROSWELL GA  30076                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VITREA CT MULTI-CHAMBER CARDIAC FUNCTIONAL ANALYSIS (CFA)
VITAL IMAGES, INC.                510(k) NO: K141302(Traditional)
ATTN: PARTHIV  SHAH               PHONE NO : 952 487-5974 
5850 Opus Pkwy Ste 300            SE DECISION MADE: 01-AUG-14
MINNETONKA MN  55343              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RICHFUL POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
SHIJIAZHUANG RICHFUL PLASTIC CO., 510(k) NO: K141305(Traditional)
ATTN: CHU  XIAOAN                 PHONE NO : 861 082 387441 
ROOM 1606 BLDG 1 JIANXIANG YUAN NOSE DECISION MADE: 27-AUG-14
BEIJING  CN 100083                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AOK POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
SHIJIAZHUANG AOK PLASTIC CO., LTD.510(k) NO: K141307(Traditional)
ATTN: CHU  XIAOAN                 PHONE NO : 861 082 387441 
ROOM 1606 BLDG 1 JIANXIANG YUAN NOSE DECISION MADE: 27-AUG-14
BEIJING  CN 100083                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NUTRA LIGHT RED
NUTRA LUXE MD, LLC                510(k) NO: K141308(Traditional)
ATTN: JILL  CREASY                PHONE NO : 775 622-9591 
5575 SANTA ROSA CT.               SE DECISION MADE: 20-AUG-14
SPARKS NV  89436                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CIANNA MEDICAL SGS SYSTEM
CIANNA MEDICAL, INC.              510(k) NO: K141318(Traditional)
ATTN: GARY  MONCNIK               PHONE NO : 949 360-0059 134
6 JOURNEY, SUITE 125              SE DECISION MADE: 27-AUG-14
ALISO VIJEO CA  92656             510(k) STATEMENT
                                                    

DEVICE: MINIMA S SYSTEM
LIMACORPORATE S.P.A.              510(k) NO: K141327(Traditional)
ATTN: STEPHEN  PEOPLES            PHONE NO : 260 645-0327 
5010 LODGE POLE LANE              SE DECISION MADE: 06-AUG-14
FORT WAYNE IN  46814              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SOURCE GUIDE TUBE WITH LOCKING MECHANISM FOR 113 MM NEEDLES, GAMMAMEDPLUS
VARIAN MEDICAL SYSTEMS, INC.      510(k) NO: K141336(Traditional)
ATTN: PETER J CORONADO            PHONE NO : 650 424-6230 
911 HANSEN WAY                    SE DECISION MADE: 06-AUG-14
PALO ALTO CA  94304               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ENDOCYN ROOT CANAL IRRIGATION SOLUTION
OCULUS INNOVATIVE SCIENCES        510(k) NO: K141352(Traditional)
ATTN: BRIAN W MARTIN              PHONE NO : 707 283-0550 
1129 N MCDOWELL BLVD              SE DECISION MADE: 18-AUG-14
PETALUMA CA  94954                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HUDSON RCI AQUAPAK HUMIDIFIER ADAPTOR
TELEFLEX MEDICAL , INC.           510(k) NO: K141353(Special)
ATTN: JAMES A COCHIE              PHONE NO : 919 433-2703 
2917 WEEK DRIVE                   SE DECISION MADE: 01-AUG-14
RESEARCH TRIANGLE PARK NC  27709  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BARRX FLEX RFA ENERGY GENERATOR
COVIDIEN IIC                      510(k) NO: K141357(Traditional)
ATTN: Tim  Thomas                 PHONE NO : 770 662-0870 1006
15 HAMPSHIRE STREET               SE DECISION MADE: 21-AUG-14
MANSFIELD MA  02048               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CLIMB MAMMOGRAPHY VIEWER SOFTWARE
CLIMB MEDICAL SYSTEMS, INC.       510(k) NO: K141364(Traditional)
ATTN: KENNETH  WADE               PHONE NO : 816 6835 8055 
SENRI LIFE SCIENCE CENTER BLDG 10FSE DECISION MADE: 29-AUG-14
TOYONAKA-SHI, OSAKA  JP 560-0082  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OTRIEVA TAPERED OVUM ASPIRATION NEEDLE SINGLE LUMEN
WILLIAM A. COOK AUSTRALIA PTY, LTD510(k) NO: K141365(Special)
ATTN: KATIE-LOU  BUSCHER          PHONE NO : 617 384 11188 
95 BRANDL ST                      SE DECISION MADE: 07-AUG-14
EIGHT MILE PLAINS, QUEENSLAND  AU 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SONICISION CORDLESS ULTRASONIC DISSECTOR
COVIDIEN, FORMERLY VALLEYLAB, A DI510(k) NO: K141371(Special)
ATTN: DAVID  HORTON               PHONE NO : 303 530-6391 
5920 Longbow Dr                   SE DECISION MADE: 07-AUG-14
BOULDER CO  80301                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MERCURY SPINAL SYSTEM
SPINAL ELEMENTS, INC.             510(k) NO: K141372(Traditional)
ATTN: JASON  BLAIN                PHONE NO : 760 607-1812 
3115 MELROSE DRIVE STE 200        SE DECISION MADE: 22-AUG-14
CARLSBAD CA  92010                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: X-REPAIR
SYNTHASOME                        510(k) NO: K141394(Special)
ATTN: ANTHONY  RATCLIFFE          PHONE NO : 858 490-9400 
3030 BUNKER HILL STREET, SUITE 308SE DECISION MADE: 06-AUG-14
SAN DIEGO CA  92109               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LITHO DK30
QUANTA SYSTEM, S.P.A.             510(k) NO: K141403(Special)
ATTN: Maurizio  Bianchi           PHONE NO : 
VIA IV NOVEMBRE,116               SE DECISION MADE: 07-AUG-14
SOLBIATE OLONA  IT 21058          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NASOPORE-FD
Polyganics BV                     510(k) NO: K141423(Special)
ATTN: BETTY  IJMKER               PHONE NO : 31 50 5886588 
ROZENBURGLAAN 15A                 SE DECISION MADE: 07-AUG-14
GRONINGEN  NL 9727-DL             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OPAL CHIRO, 20/20 P-DR
2020 IMAGING                      510(k) NO: K141435(Traditional)
ATTN: DANIEL  KAMM, P.E.          PHONE NO : 239 234-1735 
8870 RAVELLO CT.                  SE DECISION MADE: 27-AUG-14
NAPLES FL  34114                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: WHITNEY MEDICAL SOLUTIONS ESHIELD
WHITNEY MEDICAL SOLUTIONS         510(k) NO: K141438(Third Party - Traditional)
ATTN: SAAGAR  PATEL               PHONE NO : 847 966-6161 
6153C WEST MULFORD STREET         SE DECISION MADE: 14-AUG-14
NILES IL  60714                   510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: DICOMPACS DX-R WITH FLAT PANEL
OEHM UND REHBEIN GMBH             510(k) NO: K141440(Traditional)
ATTN: DANIEL  KAMM, P.E.          PHONE NO : 239 234-1735 
8870 RAVELLO CT                   SE DECISION MADE: 29-AUG-14
NAPLES FL  34114                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: INFRONT LUMBAR INTERBODY FUSION SYSTEM
INFRONT MEDICAL, LLC              510(k) NO: K141443(Traditional)
ATTN: JOHN  KUCZYNSKI             PHONE NO : 888 515-2532 
1033 US HIGHWAY 46 EAST, SUITE A20SE DECISION MADE: 28-AUG-14
CLIFTON NJ  07013                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO HEARING SCREENER WITHOUT BARCODE SCANNER,
NATUS MEDICAL INCORPORATED        510(k) NO: K141446(Special)
ATTN: JUDY  BUCKHAM               PHONE NO : 800 426-0353 5187
5900 FIRST AVENUE SOUTH           SE DECISION MADE: 22-AUG-14
SEATTLE WA  98108                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VixWin Platinum
IMAGING SCIENCES INTERNATIONAL (DB510(k) NO: K141451(Traditional)
ATTN: SANJAY  AHUJA               PHONE NO : 267 954-1463 
1910 NORTH PENN ROAD              SE DECISION MADE: 26-AUG-14
HATFIELD PA  19440                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SMC ACUPUNCTURE NEEDLE
SMC INTL., INC.                   510(k) NO: K141473(Traditional)
ATTN: JONG-MAN  LEE               PHONE NO : 822 517 2236 
JISAN IT VENTURE CENTER 601 15, BESE DECISION MADE: 01-AUG-14
SEOUL  KR 153-289                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CVI42
CIRCLE CARDIOVASCULAR IMAGING INC 510(k) NO: K141480(Traditional)
ATTN: SHIRANTHA  SAMARAPPULI      PHONE NO : 1 403 3381870 
Suite 250,  815 8th Avenue SW     SE DECISION MADE: 22-AUG-14
Calgary  CA T2P 3P2               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K141494(Special)
ATTN: ERIKKA  EDWARDSEN           PHONE NO : 800 876-3133 
1800 PYRAMID PLACE                SE DECISION MADE: 06-AUG-14
MEMPHIS TN  38132                 510(k) STATEMENT
                                                    

DEVICE: MULTI-PARAMETER MOBILE CAREGUIDE 4100 OXIMETER
REFLECTANCE MEDICAL, INC.         510(k) NO: K141496(Traditional)
ATTN: Nandini  Murthy             PHONE NO : 781 710-5378 
116 FLANDERS ROAD, SUITE 1000     SE DECISION MADE: 04-AUG-14
WESTBOROUGH MA  01581             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PORTABLE X-RAY SYSTEM (MODEL:EXARO,XRAY2GO)
OSSTEM IMPLANT CO.,LTD            510(k) NO: K141497(Special)
ATTN: PATRICK  LIM                PHONE NO : 888 678-0001 
85 BEN FAIRLESS DR.               SE DECISION MADE: 26-AUG-14
FAIRLESS HILLS PA  19030          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BASAL DIGITAL THERMOMETER
K-JUMP HEALTH CO., LTD.           510(k) NO: K141505(Special)
ATTN: JM  LIN                     PHONE NO : 886 222 991378 
NO. 56, WU KUNG 5TH RD., NEW TAIPESE DECISION MADE: 26-AUG-14
NEW TAIPEI  TW 24890              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ROMEO 2 PAD POSTERIOR AXIAL DEVICE
SPINEART                          510(k) NO: K141508(Traditional)
ATTN: FRANCK  PENNESI             PHONE NO : 41 22 7994025 
INTERNATIONAL CENTER COINTRIN 20 RSE DECISION MADE: 21-AUG-14
GENEVA  CH 1215                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ISOLA AND EXPEDIUM GROWING SPINE SYSTEMS
MEDOS SARL                        510(k) NO: K141509(Traditional)
ATTN: KIRSTEN  LEHMULLER          PHONE NO : 508 828-3291 
325 Paramount Drive               SE DECISION MADE: 22-AUG-14
Raynham MA  02767                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ZIMMER PLATES AND SCREWS (ZPS)-NON-STERILE PLATES
ZIMMER, INC.                      510(k) NO: K141517(Traditional)
ATTN: STEPHEN H MCKELVEY,MA, RAC  PHONE NO : 574 372-4944 
P.O. BOX 708                      SE DECISION MADE: 13-AUG-14
WARSAW IN  46581-0708             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MUSTANG BALLOON DILATATION CATHETER/CHARGER PTA BALLOON DILATATION CATHETER
Boston Scientific Corporation     510(k) NO: K141521(Special)
ATTN: MELANIE  RASKA              PHONE NO : 763 494-2212 
ONE SCIMED PLACE                  SE DECISION MADE: 21-AUG-14
MAPLE GROVE MN  55311             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MEDELA THOPAZ+
MEDELA AG                         510(k) NO: K141553(Special)
ATTN: ORLANDO  ANTUNES            PHONE NO : 041 561 6671 
LAETTICHSTRASSE 7B                SE DECISION MADE: 25-AUG-14
BAAR, ZUG  CH 6341                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IGROW - II HAIR GROWTH SYSTEM, IGROW HAIR GROWTH SYSTEM
APIRA SCIENCE, INC.               510(k) NO: K141567(Traditional)
ATTN: RAYMOND R BLANCHE           PHONE NO : 973 539-7444 
641 SHUNPIKE RD, STE 311          SE DECISION MADE: 21-AUG-14
CHATHAM NJ  07928                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SILVERLON ISLAND WOUND DRESSING
ARGENTUM MEDICAL                  510(k) NO: K141573(Special)
ATTN: RICH  FOSTER                PHONE NO : 630 232-2507 
2571 KANEVILLE COURT              SE DECISION MADE: 28-AUG-14
GENEVA IL  60134                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ASTROGLIDE NATURAL
BIOFILM, INC.                     510(k) NO: K141581(Traditional)
ATTN: Sherry  Castello            PHONE NO : 760 727-9030 
3225 Executive Rdg                SE DECISION MADE: 06-AUG-14
VISTA CA  92081                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SMITH & NEPHEW DISPOSABLE FIN PUNCH
SMITH & NEPHEW, INC.              510(k) NO: K141585(Traditional)
ATTN: JENNY  WALDRIP              PHONE NO : 901 399-6022 
7135 Goodlett Farms Parkway       SE DECISION MADE: 21-AUG-14
Cordova TN  38016                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UNIMICRO SUCTION IRRIATION TUBING SET
UNIMICRO MEDICAL SYSTEMS (SHENZHEN510(k) NO: K141592(Traditional)
ATTN: LONG  YANG                  PHONE NO : 86 755 86664986 
R15-08, EAST BUILDING, YIHAI PLAZASE DECISION MADE: 04-AUG-14
SHENZHEN, GUANGDONG  CN 518054    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MUSTANG BALLOON DIALATION CATHETER
Boston Scientific Corporation     510(k) NO: K141597(Special)
ATTN: MELANIE  RASKA              PHONE NO : 763 4942212 
ONE SCIMED PLACE                  SE DECISION MADE: 22-AUG-14
MAPLE GROVE MN  55311-1566        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FUTURABOND M+
VOCO GMBH                         510(k) NO: K141610(Special)
ATTN: T.  GERKENSMEIER            PHONE NO : 494 721 719200 
ANTON-FLETTNER-STRASSE 1-3        SE DECISION MADE: 01-AUG-14
CUXHAVEN  DE 27472                510(k) STATEMENT
                                                    

DEVICE: KIMGUARD ONE-STEP STERILIZATION WRAP
KIMBERLY-CLARK HEALTH CARE        510(k) NO: K141612(Special)
ATTN: MARCIA  JOHNSON             PHONE NO : 770 587-8566 
1400 HOLCOMB BRIDGE ROAD          SE DECISION MADE: 07-AUG-14
ROSWELL GA  30076                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MAGELLAN ROBOTIC SYSTEM
Hansen Medical                    510(k) NO: K141614(Traditional)
ATTN: KATE W LEE                  PHONE NO : 650 404-5841 
800 EAST MIDDLEFIELD  ROAD        SE DECISION MADE: 07-AUG-14
MOUNTAIN VIEW CA  94043           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VAPRO INTERMITTENT CATHETER
HOLLISTER, INCORPORATED           510(k) NO: K141642(Special)
ATTN: JEANNE  LEE                 PHONE NO : 847 996-6350 
2000 HOLLISTER DRIVE              SE DECISION MADE: 22-AUG-14
LIBERTYVILLE IL  60048            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BIOLOX DELTA CERAMIC OPTION HEADS
BIOMET, INC.                      510(k) NO: K141653(Traditional)
ATTN: BECKY  EARL                 PHONE NO : 574 372-1518 
56 EAST BELL DR. BOX 587          SE DECISION MADE: 18-AUG-14
WARSAW IN  46581-0587             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JUSHA-C61 LCD MONITOR
NANJING JUSHA DISPLAY TECHNOLOGY C510(k) NO: K141679(Traditional)
ATTN: LI  LE                      PHONE NO : 86 25 83305050 
8A, BLOCK 1, NANJING INTL SERVICE SE DECISION MADE: 01-AUG-14
NANJING, JIANGSU  CN 210036       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JUSHA-C33C LCD MONITOR
NANJING JUSHA DISPLAY TECHNOLOGY C510(k) NO: K141684(Traditional)
ATTN: LI  LE                      PHONE NO : 86 25 83305050 
8A, BLOCK 1 NANJING INTERNATIONAL SE DECISION MADE: 01-AUG-14
HAUZHONGMEN STREET, NANJING  CN 21510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JUSHA-M33C LCD MONITOR
NANJING JUSHA DISPLAY TECHNOLOGY C510(k) NO: K141690(Traditional)
ATTN: LI  LE                      PHONE NO : 86 25 83305050 
8A, BLOCK 1 NANJING INTERNATIONAL SE DECISION MADE: 01-AUG-14
HAUZHONGMEN STREET, NANJING  CN 21510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ZIMMER PERIARTICULAR LOCKING SYSTEM
ZIMMER, INC.                      510(k) NO: K141734(Traditional)
ATTN: STEPHEN H MCKELVEY, MA,RAC  PHONE NO : 574 372-4944 
P.O. BOX 708                      SE DECISION MADE: 13-AUG-14
WARSAW IN  46581-0708             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARTHREX ANKLE FUSION PLATING SYSTEM
ARTHREX, INC.                     510(k) NO: K141735(Special)
ATTN: LAURA  MEDLIN               PHONE NO : 239 643-5553 
1370 CREEKSIDE BLVD.              SE DECISION MADE: 15-AUG-14
NAPLES FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AS20 COMPOSITE GRAFT
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K141746(Traditional)
ATTN: LESLIE  FITCH               PHONE NO : 901 867-4120 
1023 Cherry Road --               SE DECISION MADE: 04-AUG-14
Memphis TN  38111                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PERFUSE PERCUTANEOUS DECOMPRESSION SYSTEM
BIOMET, INC.                      510(k) NO: K141762(Traditional)
ATTN: LONNIE  WITHAM              PHONE NO : 574 3711088 
56 EAST BELL DR. BOX 587          SE DECISION MADE: 27-AUG-14
WARSAW IN  46581-0587             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LOGIQ V5/LOGIQ V3
GE HEALTHCARE                     510(k) NO: K141768(Traditional)
ATTN: BRYAN  BEHN                 PHONE NO : 414 721-4214 
9900 Innovation Drive             SE DECISION MADE: 04-AUG-14
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OPTIS INTEGRATED SYSTEM, DRAGONFLY OPTIS IMAGING CATHETER
LIGHTLAB IMAGING, INC.            510(k) NO: K141769(Traditional)
ATTN: JEFFREY  ROBERTS            PHONE NO : 977 577-3451 
4 ROBBINS ROAD                    SE DECISION MADE: 18-AUG-14
WESTFORD MA  01886                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IMMULTE 2000 RUBELLA QUANTITATIVE IGG CALIBRATION VERIFICATION MATERIAL
Siemens Healthcare Diagnostics Inc510(k) NO: K141772(Abbreviated)
ATTN: Asha  Gartland              PHONE NO : 914 524-3257 
511 BENEDICT AVE.                 SE DECISION MADE: 19-AUG-14
TARRYTOWN NY  10591               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HI-TORQUE VERSATURN GUIDE WIRE
Abbott Vascular                   510(k) NO: K141782(Special)
ATTN: VIVEK  THAKKAR              PHONE NO : 408 845-0899 
3200 LAKESIDE DRIVE               SE DECISION MADE: 07-AUG-14
SANTA CLARA CA  92054             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SAGITTILT
ORFIT INDUSTRIES NV               510(k) NO: K141787(Traditional)
ATTN: Lee  Leichter               PHONE NO : 239 244-1448 
10882 STONINGTON AVE.             SE DECISION MADE: 07-AUG-14
FORT MYERS FL  33913              510(k) STATEMENT
                                                    

DEVICE: OBSIDIAN MILLING BLOCKS
PRISMATIK DENTALCRAFT, INC.       510(k) NO: K141788(Special)
ATTN: ARMIN  ZEHTABCHI            PHONE NO : 949 399-1940 
2212 DUPONT DRIVE, SUITE P        SE DECISION MADE: 20-AUG-14
IRVINE CA  92612                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEM
SYNTHES (USA) PRODUCTS LLC        510(k) NO: K141796(Traditional)
ATTN: KARA  ELKIN                 PHONE NO : 610 719-1239 
1301 Goshen Parkway               SE DECISION MADE: 29-AUG-14
West Chester PA  19380            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RHYTHMSTAR SYSTEM
RHYTHMEDIX, LLC                   510(k) NO: K141813(Third Party - Traditional)
ATTN: M.W.(ANDY)  ANDERSON        PHONE NO : 952 746-8079 
5353 WAYZATA BLVD, SUITE 505      SE DECISION MADE: 05-AUG-14
MINNEAPOLIS MN  55416             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: TURBO-JECT PICC SETS
COOK CORPORATED                   510(k) NO: K141818(Special)
ATTN: SEAN  SPENE                 PHONE NO : 812 335-3575 
60 DANIELS WAY                    SE DECISION MADE: 05-AUG-14
BLOOMINGTON IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ALTEON NECK PRESERVING FEMORAL STEM, STANDARD OFFSET, SIZE 6-7; ALTEON NECK PRESERVING FEMORAL STEM, EXTENDED OFFSET
EXACTECH, INC.                    510(k) NO: K141821(Special)
ATTN: THOMAS  MCNAMARA            PHONE NO : 352 377-1140 
2320 N.W. 66TH CT.                SE DECISION MADE: 28-AUG-14
GAINESVILLE FL  32653             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SENSEI X ROBOTIC CATHETER SYSTEM
HANSON MEDICAL, INC.              510(k) NO: K141822(Special)
ATTN: TODD  MILHOLLAND            PHONE NO : 650 404-2777 
800 EAST MIDDLEFIELD RD           SE DECISION MADE: 05-AUG-14
MOUNTAIN VIEW CA  94043           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AAP LOQTEC CLAVICLE PLATES 2.7/3.5
AAP IMPLANTATE AG                 510(k) NO: K141823(Traditional)
ATTN: CHRISTIAN  ZIETSCH          PHONE NO : 004 930 75019193 
LORENZWEG 5                       SE DECISION MADE: 07-AUG-14
BERLIN  DE D-12099                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SAPPHIRE ADMINISTRATION SET
Q CORE MEDICAL LTD                510(k) NO: K141834(Special)
ATTN: Rhona  Shanker              PHONE NO : 301 251-9570 
12154 Darnestown Road, #236       SE DECISION MADE: 05-AUG-14
Gaithersburg MD  20878            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: INTEGRA MOZAIK OSTEOCONDUCTIVE  SCAFFOLD - STRIP
INTEGRA LIFESCIENCE CORPORTATION  510(k) NO: K141841(Special)
ATTN: NICOLE C HARLAN             PHONE NO : 609 750-2836 
311 ENTERPRISE DRIVE              SE DECISION MADE: 01-AUG-14
PLAINSBORO NJ  08536              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ACUSON X700 ULTRASOUND SYSTEM, ACUSON X600 ULTRASOUND SYSTEM
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K141846(Third Party - Traditional)
ATTN: SHELLY  PEARCE              PHONE NO : 650 694-5988 
685 East Middlefield Road         SE DECISION MADE: 07-AUG-14
Mountain View CA  94043           510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: IOGYN SYSTEM
IOGYN, INC.                       510(k) NO: K141848(Special)
ATTN: RICH  CHRISTENSEN           PHONE NO : 408 996-2517 
20195 STEVENS CREEK BOULEVARD SUITSE DECISION MADE: 29-AUG-14
CUPERTINO CA  95014               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CLOSURERFG RADIOFREQUENCY GENERATOR
COVIDIEN                          510(k) NO: K141858(Special)
ATTN: Laura  Moen-Ftacek          PHONE NO : 763 398-7359 
3033 Campus Drive                 SE DECISION MADE: 05-AUG-14
Plymouth MN  55441                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/H5 SUBTYPING
CENTERS FOR DISEASE CONTROL AND PR510(k) NO: K141859(Special)
ATTN: Yon  Yu, Pharm.D.           PHONE NO : 404 639-3046 
1600 CLIFTON  ROAD, MS-C18        SE DECISION MADE: 01-AUG-14
ATLANTA GA  30333                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BREAST VOLUME NAVIGATOR
METRITRACK LLC                    510(k) NO: K141870(Third Party - Traditional)
ATTN: MIRELA  WOHLFORD            PHONE NO : 708 498-3578 
4415 W HARRISON STREET            SE DECISION MADE: 07-AUG-14
HILLSIDE IL  60162                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Straumann Bone Level NC Angled Screw Retained Abutments
STRAUMANN USA, LLC                510(k) NO: K141871(Special)
ATTN: CHRISTOPHER  KLACZYK        PHONE NO : 978 747-2575 
60 MINUTEMAN ROAD                 SE DECISION MADE: 07-AUG-14
ANDOVER MA  01810                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MEDICAL LCD MONITOR
KOSTEC  CO., LTD                  510(k) NO: K141891(Traditional)
ATTN: Priscilla  Chung            PHONE NO : 714 202-5789 
2651 E. CHAPMAN AVE STE 110       SE DECISION MADE: 04-AUG-14
FULLERTON CA  92831               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PATHASSIST LED LIGHT FIBER
Entellus Medical, Inc.            510(k) NO: K141916(Special)
ATTN: GARRETT P AHLBORG           PHONE NO : 763 463-7074 
3600 Holly Lane North, Suite 40   SE DECISION MADE: 07-AUG-14
Plymouth MN  55447                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OSSEOFLEX SB, 10G/4ML, OSSEOFLEX SB, 10G/2ML
OSSEON LLC                        510(k) NO: K141930(Special)
ATTN: KEITH  BURGER               PHONE NO : 707 636-5940 
2330 CIRCADIAN WAY                SE DECISION MADE: 21-AUG-14
SANTA ROSA CA  95407              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DLP SILICONE CORONARY ARTERY OSTIAL CANNULAE
MEDTRONIC INC.                    510(k) NO: K141951(Special)
ATTN: KEVIN T LAM                 PHONE NO : 763 526-2360 
7611 NORTHLAND DRIVE              SE DECISION MADE: 15-AUG-14
MINNEAPOLIS MN  55428             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FIBERGRAFT BG MORSELS
PROSIDYAN, INC                    510(k) NO: K141956(Special)
ATTN: JANICE M HOGAN              PHONE NO : 617 8635520 
1835 MARKET STREET, 29TH FLOOR    SE DECISION MADE: 13-AUG-14
PHILADELPIHA PA  19103            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES
PHILIPS MEDICAL SYSTEMS NETHERLAND510(k) NO: K141979(Special)
ATTN: JEANETTE  BECKER            PHONE NO : 316 113863 80 
VEENPLUIS 4-6 5684-PC             SE DECISION MADE: 19-AUG-14
BEST  NL NETHERLAND               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NEUROBLATE SYSTEM
MONTERIS MEDICAL CORP             510(k) NO: K141983(Special)
ATTN: CRAIG  COOMBS               PHONE NO : 510 337-0140 
1193 SHERMAN STREET               SE DECISION MADE: 11-AUG-14
ALAMEDA CA  94501                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: M.U.S.T PEDICLE SCREW SYSTEM
MEDACTA INTERNATIONAL             510(k) NO: K141988(Special)
ATTN: ADAM  GROSS                 PHONE NO : 805 910-6511 
1556 W. CARROLL AVENUE            SE DECISION MADE: 19-AUG-14
CHICAGO IL  60607                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VARIAX 2 SYSTEM
Stryker Trauma AG                 510(k) NO: K141992(Special)
ATTN: ESTELA  CELI                PHONE NO : 201 831-6461 
325 Corporate Drive               SE DECISION MADE: 07-AUG-14
Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BREAST SPEEDER CX, GRID HOLDER CX
QUALITY ELECTRODYNAMICS, LLC.     510(k) NO: K142002(Traditional)
ATTN: Kathleen  Aras              PHONE NO : 440 484-2964 
700 BETA DRIVE STE 100            SE DECISION MADE: 22-AUG-14
MAYFIELD VILLAGE OH  44143        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SYMBIA 6.0
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K142006(Special)
ATTN: CYNTHIA  BUSCH              PHONE NO : 847 304-7095 
2501 NORTH BARRINGTON RD.         SE DECISION MADE: 21-AUG-14
HOFFMAN ESTATES IL  60192         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SOLUTION SET/EXTENSION SET
BAXTER HEALTHCARE CORPORATION     510(k) NO: K142011(Special)
ATTN: TIFFANY  LIN                PHONE NO : 224 270-4343 
32650 N. WILSON ROAD              SE DECISION MADE: 18-AUG-14
ROUND LAKE IL  60073              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: X-PORTE ULTRASOUND SYSTEM
REGULATORY TECHNOLOGY SERVICES LLC510(k) NO: K142017(Third Party - Traditional)
ATTN: MARK  JOB                   PHONE NO : 763 682-4139 
1394 25TH STREET NW               SE DECISION MADE: 22-AUG-14
BUFFALO MN  55313                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Elecsys Estradiol III CalSet
Roche Diagnostics                 510(k) NO: K142021(Traditional)
ATTN: KELLI  TURNER               PHONE NO : 317 521-4515 
9115 HAGUE ROAD                   SE DECISION MADE: 12-AUG-14
INDIANAPOLIS IN  46250-0416       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP ADMINISTRATION SETS
B. BRAUN MEDICAL, INC.            510(k) NO: K142036(Special)
ATTN: TRACY  MADDOCK              PHONE NO : 610 596-2545 
901 MARCON BLVD.                  SE DECISION MADE: 25-AUG-14
ALLENTOWN PA  18109-9341          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE
Guangzhou Wondfo Biotech Co., Ltd.510(k) NO: K142044(Traditional)
ATTN: Joe  Shia                   PHONE NO : 240 505-7880 
504 EAST DIAMOND AVE. SUITE F     SE DECISION MADE: 25-AUG-14
GAITHERSBURG MD  20878            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED
ECOLAB, INC.                      510(k) NO: K142080(Special)
ATTN: JENNIFER  WILLNER           PHONE NO : 651 250-2080 
370 WABASHA STREET NORTH          SE DECISION MADE: 28-AUG-14
ST.PAUL MN  55102                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NIO -INTRAOSSEOUS DEVICE
WAISMED LTD.                      510(k) NO: K142086(Special)
ATTN: JONATHAN S KAHAN            PHONE NO : 202 637-5600 
555 THIRTEENTH STREET, NW COLUMBIASE DECISION MADE: 28-AUG-14
WASHINGTON DC  20004              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SELEC-3 I.V.ADMINISTRATION SET
BIOMEDIX, INC.                    510(k) NO: K142097(Special)
ATTN: MYRA J BENDER               PHONE NO : 812 355-7000 
3895 WEST VERNAL PIKE             SE DECISION MADE: 29-AUG-14
Blmgtn IN  47404                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LLD EZ
SPECTRANETICS, INC.               510(k) NO: K142116(Special)
ATTN: PHAROAH  GARMA              PHONE NO : 719 447-2385 
9965 Federal Drive                SE DECISION MADE: 12-AUG-14
Colorado Springs CO  80921        510(k) STATEMENT
                                                    

DEVICE: ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP
ATRICURE, INC.                    510(k) NO: K142120(Special)
ATTN: JONATHAN  MCELWEE           PHONE NO : 513 644-4249 
6217 CENTRE PARK DRIVE            SE DECISION MADE: 28-AUG-14
WEST CHESTER OH  45069            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VALOR HINDFOOT FUSION NAIL SYSTEM
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K142121(Special)
ATTN: JEANINE  REDDEN             PHONE NO : 901 867-4522 
1023 CHERRY ROAD                  SE DECISION MADE: 21-AUG-14
MEMPHIS TN  38117                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: REDUCE FRACTURE PLATING SYSTEM LINE EXTENSION
ICON ORTHOPEDIC CONCEPTS, LLC DBA 510(k) NO: K142135(Special)
ATTN: JAN  TRIANI                 PHONE NO : 201 543-9388 
6 MARS COURT, UNIT 6-3            SE DECISION MADE: 28-AUG-14
BOONTON NJ  07005                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ORTHOHELIX STAPLE SYSTEM
ORTHOHELIX SURGICAL DESIGNS, INC. 510(k) NO: K142148(Special)
ATTN: BRIAN  HOCKETT              PHONE NO : 330 869-9562 
1065 Medina Rd. SUITE 500         SE DECISION MADE: 21-AUG-14
Medina OH  44256                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TOTAL SHIELD SURGICAL;TOGA(REGULAR, LARGE,X-LARGE);HOOD; HELMET ADVANCED HELMET W/LED LIGHTING, TOTAL SHIELD ACCESSORIES
ZIMMER, INC.                      510(k) NO: K142166(Special)
ATTN: ANGELA  ESTRADA             PHONE NO : 330 343-8801 
200 W. OHIO AVE.                  SE DECISION MADE: 28-AUG-14
DOVER OH  44622                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MEMO 3D ReChord
SORIN GROUP ITALIA S.R.L          510(k) NO: K142221(Special)
ATTN: MAURO  ERCOLANI             PHONE NO : 39 0161 487412 
VIA CRESCENTINO SN                SE DECISION MADE: 29-AUG-14
SALUGGIA  IT 13040                510(k) SUMMARY AVAILABLE FROM FDA
                                                    


                                                 TOTAL 510(k)s THIS PERIOD   265                                     
                                                 TOTAL WITH SUMMARIES        244                                     
                                                 TOTAL WITH STATEMENTS        21
                                      

 

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