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
