Medical Devices
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February 2013 510(k) Clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD February 2013 DEVICE: DEKA SMARTXIDE AND DELIVERY ACCESSORIES EL.EN. ELECTRONIC ENGINEERING SPA 510(k) NO: K113504(TRADITIONAL) ATTN: PAOLO PERUZZI PHONE NO : 390 558 826407 17 VIA BALDANZESE SE DECISION MADE: 01-FEB-13 CALENZANO IT 50041 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MILAGRO ADVANCE INTERFERENCE SCREW DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K123362(TRADITIONAL) ATTN: YAYOI FUJIMAKI PHONE NO : 508 828 3541 325 PARAMOUNT DR. SE DECISION MADE: 01-FEB-13 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INCORIS TZI SIRONA DENTAL SYSTEMS GMBH 510(k) NO: K123545(TRADITIONAL) ATTN: FRITZ KOLLE PHONE NO : 496 251163 294 FABRIKSTRASSE 31 SE DECISION MADE: 01-FEB-13 BENSHEIM GM D-64625 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUVASIVE LONG LATERAL SPINAL SYSTEM NUVASIVE, INC. 510(k) NO: K122081(SPECIAL) ATTN: ELIAS KETCHUM PHONE NO : 858 320 4588 7475 LUSK BLVD SE DECISION MADE: 01-FEB-13 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNGO, BREAST CARE SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K123420(TRADITIONAL) ATTN: PATRICIA D JONES PHONE NO : 610 448 3536 51 VALLEY STREAM PKWY. SE DECISION MADE: 01-FEB-13 MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARKRAY AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM ARKRAY, INC. 510(k) NO: K121456(TRADITIONAL) ATTN: ADAM ETTL PHONE NO : 952 646 3142 5182 WEST 76TH STREET SE DECISION MADE: 01-FEB-13 EDINA MN 55439 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE LATEX PATIENT EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM, NATURAL COLOR ASSURGUARD SDN. BHD. 510(k) NO: K123757(TRADITIONAL) ATTN: LIM H GUAN PHONE NO : 603 329710 20 82F, JALAN PULASAN KLANG SE DECISION MADE: 01-FEB-13 SELANGOR DARUL EHSAN MY 41000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOVEL FIT AND FILL STEM HOWMEDICA OSTEONICS CORP 510(k) NO: K122853(TRADITIONAL) ATTN: VALERIE GIAMBANCO PHONE NO : 201 831 6275 325 CORPORATE DR. SE DECISION MADE: 01-FEB-13 MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EASYSPINE SYSTEM LDR SPINE USA INC. 510(k) NO: K123134(TRADITIONAL) ATTN: MARITZA ELIAS PHONE NO : 512 344 3371 13785 RESEARCH BOULEVARD SUITE 200SE DECISION MADE: 01-FEB-13 AUSTIN TX 78750 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARCHITECT TOTAL BILIRUBIN ABBOTT LABORATORIES 510(k) NO: K121985(TRADITIONAL) ATTN: LINDA MORRIS PHONE NO : 972 518 6711 1921 HURD DRIVE SE DECISION MADE: 01-FEB-13 IRVING TX 75038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE B ROCKET MEDICAL PLC 510(k) NO: K123033(TRADITIONAL) ATTN: TRACY CHARLTON PHONE NO : 004 419 14194488 FACTORIES 2& 4, SEDLING RD WEAR INSE DECISION MADE: 01-FEB-13 WASHINGTON, TYNE & WEAR UK NE38510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANTERIOR CERVICAL PLATE SYSTEM WEIGAO ORTHOPAEDIC DEVICE CO., LTD510(k) NO: K123578(TRADITIONAL) ATTN: DIANA HONG PHONE NO : 86 21 22815850 PO BOX 237-023 SE DECISION MADE: 01-FEB-13 SHANGHAI CH 200237 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PLANMED VERITY PLANMED OY 510(k) NO: K121418(TRADITIONAL) ATTN: LARS MORING PHONE NO : 358 207 795300 Sorvaajankatu 7 SE DECISION MADE: 01-FEB-13 Helsinki FI 00880 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIOLASE 10S BIOLASE TECHNOLOGY, INC. 510(k) NO: K121327(TRADITIONAL) ATTN: ROBERT YANG PHONE NO : 949 361 1200 4 CROMWELL SE DECISION MADE: 01-FEB-13 IRVINE CA 92618 1816 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ICS IMPULSE GN OTOMETRICS 510(k) NO: K122550(TRADITIONAL) ATTN: DANIEL KAMM PHONE NO : 239 234 1735 8870 RAVELLO CT SE DECISION MADE: 01-FEB-13 NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: E-CUBE 15 ALPINION MEDICAL SYSTEMS CO., LTD 510(k) NO: K123610(TRADITIONAL) ATTN: DONGHWAN KIM PHONE NO : 82 70 74652068 1, 6 AND 7FL, VERDI TOWER 72, DIGISE DECISION MADE: 01-FEB-13 SEOUL KS 152-848 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INVIVO DENTAL ANATOMAGE, INC 510(k) NO: K123519(TRADITIONAL) ATTN: MIKE MENDEZ PHONE NO : 408 885 1474 111N. MARKET ST, STE 800 SE DECISION MADE: 01-FEB-13 SAN JOSE CA 95113 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DORNIER MEDILAS H30 SOLVO DORNIER MEDTECH AMERICA, INC. 510(k) NO: K122159(SPECIAL) ATTN: JOHN HOFFER PHONE NO : 770 514 6163 1155 ROBERTS BLVD. SE DECISION MADE: 01-FEB-13 KENNESAW GA 30144 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWARE SMITHS MEDICAL ASD, INC. 510(k) NO: K111275(TRADITIONAL) ATTN: JULIE TAPPER PHONE NO : 651 628 7018 1265 GREY FOX ROAD SE DECISION MADE: 01-FEB-13 ARDEN HILLS MN 55112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EPIEN ROOT CANAL CLEANSER EPIEN MEDICAL, INC. 510(k) NO: K123538(TRADITIONAL) ATTN: JEFFREY K SHAPIRO PHONE NO : 202 737 9633 700 THIRTEENTH ST. NW STUITE 200 SE DECISION MADE: 01-FEB-13 WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICRODOSE SI PHILIPS DIGITAL MAMMOGRAPHY SWEDEN510(k) NO: K123995(SPECIAL) ATTN: GUSTAV LINS PHONE NO : 468 623 5200 SMIDESVAGEN 5 SE DECISION MADE: 01-FEB-13 SOLNA SW SE-171 41 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIVIX-S WIRELESS VIEWORKS CO., LTD. 510(k) NO: K122865(TRADITIONAL) ATTN: PRISCILLA CHUNG PHONE NO : 714 869 3080 951 STARBUCK ST UNIT J SE DECISION MADE: 01-FEB-13 FULLERTON CA 92833 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CIANNA MEDICAL TISSUE MARKER AND DELIVERY SYSTEM CIANNA MEDICAL 510(k) NO: K120804(TRADITIONAL) ATTN: GARY MOCNIK PHONE NO : 949 360 0059 6 JOURNEY, SUITE 125 SE DECISION MADE: 04-FEB-13 ALISO VIEJO CA 92656 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WRIST PULSE OXIMETER BEIJING CHOICE ELECTRONIC TECHNOLO510(k) NO: K122046(TRADITIONAL) ATTN: LEI CHEN PHONE NO : 861 088 790480 NO. 9 SHUANGYUAN RD. SHIJINGSHAN DSE DECISION MADE: 04-FEB-13 BEIJING CH 100041 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUTOMATED ENDOSCOPE LEAK TESTER OLYMPUS MEDICAL SYSTEMS CORP. 510(k) NO: K123704(TRADITIONAL) ATTN: DAPHNEY GERMAIN-KOLAWOLE PHONE NO : 484 896 5691 REGULATORY AFFAIRS & QUALITY ASSURSE DECISION MADE: 04-FEB-13 CENTER VALLEY PA 18034 0610 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VARI-PASS VARIABLE LENGTH ACCESS SHEATH OLYMPUS SURGICAL TECHNOLOGIES AMER510(k) NO: K123170(SPECIAL) ATTN: DEANA BOUSHELL PHONE NO : 508 804 2752 136 TURNPIKE ROAD SE DECISION MADE: 04-FEB-13 SOUTHBOROUGH MA 01772 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: A-GRIX TE RESORABLE BONE VOID FILLER AG DIGITAL TECHNOLOGY CORP. 510(k) NO: K121453(TRADITIONAL) ATTN: JENNIFER REICH PHONE NO : 928 853 6340 2904 N. BOLDT DRIVE SE DECISION MADE: 05-FEB-13 FLAGSTAFF AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I AND MIDSTREAM II) NANTONG BIOTECHNOLOGY CO., LTD. 510(k) NO: K123050(TRADITIONAL) ATTN: JOE XIA PHONE NO : 301 250 0831 12828 DOE LANE SE DECISION MADE: 05-FEB-13 GAITHERSBURG MD 20878 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RELIAMAX GASTROINTESTINAL ANASTOMOSIS AND RELOAD COVIDIEN, FORMERLY US SURGICAL A D510(k) NO: K122781(TRADITIONAL) ATTN: MARY MELLOWS PHONE NO : 203 492 5284 60 Middletown Ave SE DECISION MADE: 05-FEB-13 North Haven CT 06473 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VISCOSTAT CLEAR ULTRADENT PRODUCTS, INC. 510(k) NO: K123215(TRADITIONAL) ATTN: KAREN KAKUNES PHONE NO : 801 553 4366 505 WEST 10200 SOUTH SE DECISION MADE: 05-FEB-13 SOUTH JORDAN UT 84095 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIFESPAN EPTFE VASCULAR GRAFT LEMAITRE VASCULAR, INC. 510(k) NO: K130016(SPECIAL) ATTN: XIANG ZHANG PHONE NO : 781 425 1729 63 2ND AVENUE SE DECISION MADE: 05-FEB-13 BURLINGTON MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PARCUS DRAW TIGHT 1.8MM SINGLE-LOADED SUTURE ANCHOR PARCUS MEDICAL, LLC 510(k) NO: K122805(TRADITIONAL) ATTN: PAUL VAGTS PHONE NO : 920 746 2972 839 SOUTH NEENAH AVE. SE DECISION MADE: 05-FEB-13 STURGEON BAY WI 54235 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUGMENT AND SCREW, PSA TYPE UNITED ORTHOPEDIC CORP. 510(k) NO: K122183(TRADITIONAL) ATTN: FANG-YUAN HO PHONE NO : 886 357 73351X2212 57 PARK AVE. 2, SCIENCE PARK SE DECISION MADE: 05-FEB-13 HSINCHU TW 300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GIRAFFE AND PANDA WARMERS OHMEDA MEDICAL 510(k) NO: K123309(TRADITIONAL) ATTN: AGATA ANTHONY PHONE NO : 410 888 5200 8880 GORMAN RD. SE DECISION MADE: 05-FEB-13 LAUREL MD 20723 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL THERMOMTER TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K122520(TRADITIONAL) ATTN: PINJUNG CHEN PHONE NO : 886 266 258188 6F, NO. 127, WUGONG 2ND RD WUGU DISE DECISION MADE: 05-FEB-13 NEW TAIPEI CITY TW 24888 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PASS LP SPINAL SYSTEM MEDICREA INTERNATIONAL 510(k) NO: K123138(TRADITIONAL) ATTN: LAURE AVIRON-VIOLET PHONE NO : 334 72 018787 14 PORTE DU GRAND LYON SE DECISION MADE: 05-FEB-13 NEYRON FR 01700 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ETHICON SECURESTRAP OPEN ABSORBABLE STRAP FIXATION DEVICE ETHICON, INC. 510(k) NO: K123114(TRADITIONAL) ATTN: SUSAN LIN PHONE NO : 908 218 2256 ROUTE 22 WEST P.O. BOX 151 SE DECISION MADE: 05-FEB-13 SOMERVILLE NJ 08876 0151 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDEASCREEN CARDEA ASSOCIATES INC 510(k) NO: K123217(TRADITIONAL) ATTN: DAVID M HADLEY PHONE NO : 800 855 0760 137220 220TH PLACE NE SE DECISION MADE: 05-FEB-13 WOODINVILLE WA 98077 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PROFEMUR Z CLASSIC STEMS WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K123434(SPECIAL) ATTN: DAVID FITCH PHONE NO : 901 290 5945 5677 AIRLINE RD. SE DECISION MADE: 05-FEB-13 ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRC-NW300 NON-MYDRIATIC RETINAL CAMERA TOPCON MEDICAL SYSTEMS, INC. 510(k) NO: K123460(TRADITIONAL) ATTN: MICHAEL GUSEL PHONE NO : 201 599 5553 111 Bauer Dr SE DECISION MADE: 06-FEB-13 Oakland NJ 07436 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAAS INTRAVASCULAR PIE MEDICAL IMAGING B.V. 510(k) NO: K123970(TRADITIONAL) ATTN: FLORIE DANIELS PHONE NO : 31 433281 328 BECANUSSTRAAT 13 D SE DECISION MADE: 06-FEB-13 MAASTRICHT NL 6216 BX 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VISUAL-ICE CRYOABLATION SYSTEM GALIL MEDICAL INC. 510(k) NO: K123865(SPECIAL) ATTN: AMY MCKINNEY PHONE NO : 651 287 5096 6518 TAMARIND SKY LN SE DECISION MADE: 06-FEB-13 FULSHEAR TX 77441 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APLIO 500/400/300 V3.0 TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K123992(SPECIAL) ATTN: CHARLEMAGNE CHUA PHONE NO : 714 669 7896 2441 MICHELLE DRIVE SE DECISION MADE: 06-FEB-13 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASAHI REXEED-SX/LX SERIES DIALYZER ASAHI KASEI MEDICAL CO., LTD. 510(k) NO: K121409(TRADITIONAL) ATTN: PATSY TRISLER PHONE NO : 301 652 5344 154 MAIN STREET, STE 2 SE DECISION MADE: 06-FEB-13 CHARLESTOWN NH 03603 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE DATEX-OHMEDA AVANCE CS2 DATEX-OHMEDA, INC. 510(k) NO: K123125(SPECIAL) ATTN: JAMES P RASKOB PHONE NO : 608 221 1551 3030 OHMEDA DRIVE PO BOX 7550 SE DECISION MADE: 06-FEB-13 MADISON WI 53707 7550 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREP BECTON, DICKINSON AND COMPANY 510(k) NO: K122718(TRADITIONAL) ATTN: GREGORY P PAYNE PHONE NO : 858 795 7890 10865 ROAD TO THE CURE, SUITE 200 SE DECISION MADE: 06-FEB-13 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHEATHES STERILE ULTRASOUND GEL SHEATHING TECHNOLOGIES, INC. 510(k) NO: K130041(TRADITIONAL) ATTN: JENNIFER DOWNING PHONE NO : 408 782 2720 18431 TECHNOLOGY DR. SE DECISION MADE: 06-FEB-13 MORGAN HILL CA 95037 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EEGER4 MODEL 4.3 EEG SOFTWARE LLC 510(k) NO: K122879(TRADITIONAL) ATTN: HOWARD LIGHTSTONE PHONE NO : 818 886 2585 17625 MAYALL STREET SE DECISION MADE: 06-FEB-13 NORTHRIDGE CA 91325 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHERPA PAK CARDIAC TRANSPORT SYSTEM PARAGONIX TECHNOLOGIES, INC. 510(k) NO: K123326(TRADITIONAL) ATTN: LEO BASTA PHONE NO : 617 834 9866 755 WESTMINISTER STREET UNIT 120 SE DECISION MADE: 06-FEB-13 PROVIDENCE MA 02903 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE OXFORD PERFORMANCE MATERIALS 510(k) NO: K121818(TRADITIONAL) ATTN: LEIGH AYRES PHONE NO : 860 698 9300 30 S SATELLITE ROAD SE DECISION MADE: 07-FEB-13 SOUTH WINDSOR CT 06074 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATION LIFESCAN, INC. 510(k) NO: K120558(TRADITIONAL) ATTN: ANDREA TASKER PHONE NO : 610 651 7282 200 LAWRENCE DRIVE MAILSTOP C-2-2 SE DECISION MADE: 07-FEB-13 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: M2 WRIST MRI SYSTEM ASPECT IMAGING LTD 510(k) NO: K120701(TRADITIONAL) ATTN: AHAVA STEIN PHONE NO : 972 976 70002 20 HATA'AS ST (OPB 124) SE DECISION MADE: 07-FEB-13 KFAR SABA IS 44425 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAXIM SURGICAL X-TREME INTERBODY FUSION SYSTEM MAXIM SURGICAL 510(k) NO: K123206(TRADITIONAL) ATTN: CHRIS REEG PHONE NO : 214 564 1350 1565 NORTH CENTRAL EXPRESSWAY SUITSE DECISION MADE: 07-FEB-13 RICHARDSON TX 75080 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 0.9% SODIUM CHLORIDE INJECTION USP BD POSIFLUSH FLUSH SYRINGE, SF FLUSH SYRINGE BECTON DICKINSON & CO. 510(k) NO: K121050(TRADITIONAL) ATTN: JOHN ROBERTS PHONE NO : 201 847 5473 1 BECTON DRIVE SE DECISION MADE: 07-FEB-13 FRANKLIN LAKES NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TOXCUP DRUG SCREEN CUP BRANAN MEDICAL CORP. 510(k) NO: K122633(TRADITIONAL) ATTN: OLIVIA CHAN PHONE NO : 949 598 7166 140 Technology Dr Ste 400 SE DECISION MADE: 07-FEB-13 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RELIANCE SPINAL SCREW SYSTEM RELIANCE MEDICAL SYSTEMS, LLC 510(k) NO: K123521(SPECIAL) ATTN: BRET M BERRY PHONE NO : 801 295 3280 P.O. BOX 1693 SE DECISION MADE: 07-FEB-13 BOUNTIFUL UT 84010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XIPHOS DIFUSION TECHNOLOGIES 510(k) NO: K123969(TRADITIONAL) ATTN: KAREN E WARDEN, PHD PHONE NO : 440 729 8457 PO BOX 566 SE DECISION MADE: 07-FEB-13 CHESTERLAND OH 44026 2141 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPECTRUM SPINE LAMINOPLASTY PLATING SYSTEM SPECTRUM SPINE, LLC 510(k) NO: K122822(TRADITIONAL) ATTN: MEREDITH MAY PHONE NO : 719 337 7579 4628 NORTHPARK DRIVE SE DECISION MADE: 07-FEB-13 COLORADO SPRINGS CO 80918 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPINEOLOGY SPINOUS PROCESS PLATE SPINEOLOGY, INC. 510(k) NO: K123232(TRADITIONAL) ATTN: BRYAN BECKER PHONE NO : 651 256 8534 7800 3RD ST N., SUITE 600 SE DECISION MADE: 07-FEB-13 ST. PAUL MN 55128 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AIMAGO EASYLDI MICROCIRCULATION CAMERA (STAND PLUS CAMERA ARM), AIMAGO EASY LDI STAND, INCLUDING 4-WHEELED STAND BASE AN AIMAGO SA 510(k) NO: K123216(TRADITIONAL) ATTN: MARC ANDRE PHONE NO : 41 21 5105561 Parc Scientifique EPFL D 4TH FLOORSE DECISION MADE: 07-FEB-13 Lausanne SZ 1015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208 ST. JUDE MEDICAL 510(k) NO: K122587(SPECIAL) ATTN: HARLAN JONES PHONE NO : 651 756 3429 14901 DEVEAU PL. SE DECISION MADE: 07-FEB-13 MINNETONKA MN 55345 2126 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNIT SELECTIVEMED COMPONENTS INC. 510(k) NO: K120922(ABBREVIATED) ATTN: DANIEL KAMM PHONE NO : 239 234 1735 8870 RAVELLO CT SE DECISION MADE: 07-FEB-13 NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GENASIS SCANVIEW SYSTEM APPLIED SPECTRAL IMAGING, LTD. 510(k) NO: K122554(TRADITIONAL) ATTN: ILAN SHARON PHONE NO : 972 52 8704904 A-109 NETO- GOLF SE DECISION MADE: 07-FEB-13 CAESAREA IS 30889 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ESPIN NLT SPINE LTD 510(k) NO: K130057(SPECIAL) ATTN: JOHN J SMITH PHONE NO : 202 637 3638 555 THIRTEENTH STREET NW SE DECISION MADE: 07-FEB-13 WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPRESSYN STAPLE DALLEN MEDICAL, INC. 510(k) NO: K122871(TRADITIONAL) ATTN: AL MEMMOLO PHONE NO : 949 218 0030 1046 Calle Recodo Ste G SE DECISION MADE: 07-FEB-13 San Clemente CA 92673 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ONETOUCH VERIO SYNC BLOOD GLUCOSE MONITORING SYSTEM CILAG GMBH INTERNATIONAL 510(k) NO: K120708(TRADITIONAL) ATTN: NADINE NASR PHONE NO : 408 956 4079 1000 GIBRALTAR DRIVE SE DECISION MADE: 07-FEB-13 MILPITAS CA 95035 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LINSHI NITRILE DISPOSABLE EXAM GLOVES, POWDER-FREE PUYANG LINSHI HEALTH CO., LTD 510(k) NO: K123488(TRADITIONAL) ATTN: LAURA WENG PHONE NO : 626 581 3030 17800 CASTLETON ST. SUITE 328 SE DECISION MADE: 08-FEB-13 CITY OF INDUSTRY CA 91748 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORONIS FUSION 6MP BARCO N.V. 510(k) NO: K130103(SPECIAL) ATTN: LIEVEN DE WANDEL PHONE NO : 32 562332 11 PRESIDENT KENNEDYPARK 35 SE DECISION MADE: 08-FEB-13 KORTRIJK BE 8500 510(k) STATEMENT DEVICE: ALEXIS O WOUND PROTECTOR/RETRACTOR APPLIED MEDICAL RESOURCES CORP. 510(k) NO: K113268(TRADITIONAL) ATTN: FRANS VANDENBROEK PHONE NO : 949 713 8369 22872 AVENIDA EMPRESA SE DECISION MADE: 08-FEB-13 RANCHO SANTA MARGARITA CA 92688 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIAGNOSTIC ULTRASOUND SYSTEM EDAN INSTRUMENTS, INC. 510(k) NO: K123249(TRADITIONAL) ATTN: RANDY JIANG PHONE NO : 860 755268 56469 EQUIPMENTS PARK, NANHAI RD 1019 NOSE DECISION MADE: 08-FEB-13 SHENZHEN CH 518067 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MYOSURE INTRUMENT TRAY HOLOGIC, INC. 510(k) NO: K121280(TRADITIONAL) ATTN: DANIEL F PHELAN PHONE NO : 805 262 8851 250 CAMPUS DRIVE SE DECISION MADE: 08-FEB-13 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PULSTAR LOGIX INTERMITTENT PNEUMATIC COMPRESSION SYSTEM ALBAHEALTH, L.L.C. 510(k) NO: K123308(TRADITIONAL) ATTN: PATRICK FRANK PHONE NO : 865 354 0410 425 NORTH GATEWAY AVE. SE DECISION MADE: 08-FEB-13 ROCKWOOD TN 37854 510(k) STATEMENT DEVICE: VICTUS FEMTOSECOND LASER PLATFORM TECHNOLAS PERFECT VISION GMBH 510(k) NO: K122386(TRADITIONAL) ATTN: BETTY M JOHNSON PHONE NO : 714 273 8254 PO BOX 17190 SE DECISION MADE: 08-FEB-13 ANAHEIM CA 92817 7190 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNI-GOLD CRYPTOSPORIDIUM TRINITY BIOTECH 510(k) NO: K121565(TRADITIONAL) ATTN: LUPE KAGAN PHONE NO : 760 929 0500 5919 FARNSWORTH CT. SE DECISION MADE: 08-FEB-13 CARLSBAD CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADENOVIRUS R-GENE US ARGENE SA 510(k) NO: K121942(TRADITIONAL) ATTN: ERIC BRISSON PHONE NO : 335 616 96100 PARC TECHNOLOGIQUE DELTA SUD SE DECISION MADE: 08-FEB-13 VARILHES FR 09120 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PSYCHEMEDICS MICROPLATE EIA FOR OXYCODONE IN HAIR PSYCHEMEDICS CORP. 510(k) NO: K123799(TRADITIONAL) ATTN: VIRGINIA HILL PHONE NO : 310 216 7776 5832 UPLANDER WAY SE DECISION MADE: 08-FEB-13 CULVER CITY CA 90230 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ST AIA-PACK 25-OH VITAMIN D, ST AIA-PACK 25-OH VITAMIN D CALIBRATOR SET, AIA-PACK 25-OH VITAMIN D CONTROL SET, AND ST AI TOSOH BIOSCIENCE, INC. 510(k) NO: K123131(TRADITIONAL) ATTN: ROBERT L WICK PHONE NO : 650 636 8117 6000 SHORELINE COURT SUITE 101 SE DECISION MADE: 08-FEB-13 SOUTH SAN FRANCISCO CA 94080 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURGERY REHEARSAL PLATFORM SURGICAL THEATER, LLC 510(k) NO: K123023(TRADITIONAL) ATTN: MORDECHAI AVISAR PHONE NO : 216 496 7884 151 INNOVATION DR. SE DECISION MADE: 08-FEB-13 ELYRIA OH 44141 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROFEMUR TL CLASSIC HIP STEM WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K123688(SPECIAL) ATTN: YUAN LI PHONE NO : 901 867 4146 5677 AIRLINE RD. SE DECISION MADE: 08-FEB-13 ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPACT DIGITAL BLOOD PRESSURE MONITOR THERMOR LTD. 510(k) NO: K122810(TRADITIONAL) ATTN: MARK BEATON PHONE NO : 800 387 8520 16975 LESLIE ST. SE DECISION MADE: 08-FEB-13 NEWMARKET CA L3Y 9A1 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 4MP COLOR LCD MONITOR, RADIFORCE RX 440 EIZO NANAO CORPORATION 510(k) NO: K130070(TRADITIONAL) ATTN: HIROAKI HASHIMOTO PHONE NO : 817 627424 68 153 SHIMOKASHIWANO SE DECISION MADE: 08-FEB-13 HAKUSAN JA 924-8566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTIMA CT520 GE HANGWEI MEDICAL SYSTEMS CO., LT510(k) NO: K123596(TRADITIONAL) ATTN: HELEN PENG PHONE NO : 262 424 8222 NO. 2 N. YONGCHANG STREET BEIJINGSE DECISION MADE: 08-FEB-13 BEIJING CH 100176 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE ORMCO CORP. 510(k) NO: K122065(TRADITIONAL) ATTN: WENDY GARMAN PHONE NO : 714 516 7602 1717 WEST COLLINS AVENUE SE DECISION MADE: 08-FEB-13 ORANGE CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS HEINZ KURZ GMBH MEDIZINTECHNIK 510(k) NO: K112616(TRADITIONAL) ATTN: KRISTINA BITZER PHONE NO : 497 072 917939 AMSTEL 320-1 SE DECISION MADE: 08-FEB-13 AMSTERDAM NL 1017 AP 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: J-SCOPE SYSTEM MYELOTEC 510(k) NO: K122411(ABBREVIATED) ATTN: BLIX WINSTON PHONE NO : 304 607 9185 2600 MULLINIX MILL ROAD SE DECISION MADE: 11-FEB-13 MT. AIRY MD 21771 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOLEA CONVERGENT DENTAL, INC 510(k) NO: K123494(TRADITIONAL) ATTN: CARRIE HETRICK PHONE NO : 512 327 9997 611 WEST 5TH STREET THIRD FLOOR SE DECISION MADE: 11-FEB-13 AUSTIN TX 78701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FILMARRAY RESPIRATORY PANEL (RP) BIOFIRE DIAGNOSTICS, INC. 510(k) NO: K123620(TRADITIONAL) ATTN: BETH LINGENFELTER PHONE NO : 801 736 6354 390 WAKARA WAY SE DECISION MADE: 11-FEB-13 SALT LAKE CITY UT 84108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM CERAGEM MEDISYS INC. 510(k) NO: K102751(TRADITIONAL) ATTN: GRACE KIM PHONE NO : 213 480 7105 3699 WILSHIRE BLVD., STE 930 SE DECISION MADE: 11-FEB-13 LOS ANGELES CA 90010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IPL THERAPY SYSTEM BEIJING SINCOHEREN S&T DEVELOPMENT510(k) NO: K123435(TRADITIONAL) ATTN: MIKE GU PHONE NO : 86 206 2321333 7TH FLOOR 982 CONGYUN ROAD, BAIYUNSE DECISION MADE: 11-FEB-13 GUANGZHOU, GUANGDONG CH 510420 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3M VFLEX HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK 3M COMPANY 510(k) NO: K121069(TRADITIONAL) ATTN: JIZHONG JIN PHONE NO : 651 733 6655 3M CENTER, BLDG. 275-5W-06 SE DECISION MADE: 11-FEB-13 ST. PAUL MN 55144 1000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHLORINATED POWDER FREE NITRILE EXAMINATION GLOVES (BLACK COLOUR) WORLDMED MANUFACTURING SDN. BHD. 510(k) NO: K123116(TRADITIONAL) ATTN: OOI LOON SENG PHONE NO : 605 82 95555 Lot 18873, Jalan Perusahaan3, KamuSE DECISION MADE: 11-FEB-13 Kamunting MY 34600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BABYLANCE HEEL INCISION DEVICE MEDIPURPOSE PTE. LTD. 510(k) NO: K130132(SPECIAL) ATTN: JULIE STEPHENS PHONE NO : 678 513 0693 111 LAUREL RIDGE DRIVE SE DECISION MADE: 11-FEB-13 ALPHARETTA GA 30004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHONAK TINNITUS BALANCE PHONAK LLC 510(k) NO: K123450(ABBREVIATED) ATTN: LAURA ELLMAN PHONE NO : 630 821 5000 4520 WEAVER PARKWAY SE DECISION MADE: 11-FEB-13 WARRENVILLE IL 60555 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRINITY NON-OCCLUDED TITANIUM PLASMA SPRAYED (TPS) ACETABULAR SHELLS CORIN USA 510(k) NO: K123705(TRADITIONAL) ATTN: DIANA L MARTONE PHONE NO : 813 977 4469 5670 W. CYPRESS ST. SUITE C SE DECISION MADE: 12-FEB-13 TAMPA FL 33607 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCU-CHECK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM ROCHE DIAGNOSTICS 510(k) NO: K113614(TRADITIONAL) ATTN: MICHAEL FLIS PHONE NO : 317 521 2110 9115 HAGUE ROAD SE DECISION MADE: 12-FEB-13 INDIANAPOLIS IN 46250 0457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM TELEFLEX MEDICAL, INC. 510(k) NO: K130043(SPECIAL) ATTN: NATALIE SMITH PHONE NO : 919 433 8049 2917 WECK DR. SE DECISION MADE: 12-FEB-13 RESEARCH TRIANGLE PARK NC 27709 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FORYOU NPWT DEVICE FORYOU MEDICAL ELECTRONICS CO, LTD510(k) NO: K113236(TRADITIONAL) ATTN: SCOTT WRIGHT PHONE NO : 724 996 6206 3919 WILLIAM PENN HIGHWAY, SUITE 2SE DECISION MADE: 12-FEB-13 MURRYSVILLE PA 15668 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNGO MR B19 FOR MAGNETOM AVANTO, SYNGO MR B19 FOR MAGNETOM ESPREE, SYNGO MR B19 FOR MAGNETOM SYMPHONY A TIM SYSTEM, SYN SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K123938(TRADITIONAL) ATTN: NADIA SOOKDEO PHONE NO : 610 448 4918 51 VALLEY STREAM PKWY. SE DECISION MADE: 12-FEB-13 MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STA COMPACT MAX DIAGNOSTICA STAGO, INCORPORATED 510(k) NO: K130090(SPECIAL) ATTN: CARLO D'ALESSANDRO PHONE NO : 390 657 82665 PIAZZA ALBANIA, 10 SE DECISION MADE: 12-FEB-13 ROME IT 00153 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEW STETIC ARTIFICIAL TEETH NEW STETIC 510(k) NO: K122925(TRADITIONAL) ATTN: JOHN OBRIEN PHONE NO : 813 645 2855 445 APOLLO BEACH BLVD SE DECISION MADE: 12-FEB-13 APOLLO BEACH FL 33572 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI DAKO NORTH AMERICA, INC. 510(k) NO: K120663(TRADITIONAL) ATTN: XIAOLEI XU PHONE NO : 805 566 3013 6392 VIA REAL SE DECISION MADE: 12-FEB-13 CARPINTERIA CA 93013 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GIBRALT OCCIPITAL PLATE SCREWS, SET SCREW, GIBRALT OCCIPITAL SYSTEM ARTICULATING ROD, GIBRALT OCCIPITAL PLATES EXACTECH, INC. 510(k) NO: K121877(TRADITIONAL) ATTN: VLADISLAVA ZAITSEVA PHONE NO : 352 377 1140 2320 N.W. 66TH CT. SE DECISION MADE: 12-FEB-13 GAINESVILLE FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RAPIDCROSS PTA RAPID EXCHANGE, BALLOON DILATATION CATHETER EV3 INC 510(k) NO: K123544(TRADITIONAL) ATTN: LAURA J LIND PHONE NO : 763 398 7000 3033 CAMPUS DRIVE SE DECISION MADE: 12-FEB-13 PLYMOUTH MN 55441 2651 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDHELL RESERVOIR, INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED SORIN GROUP ITALIA S.R.L. 510(k) NO: K130209(SPECIAL) ATTN: SCOTT LIGHT PHONE NO : 303 467 6313 14401 W. 65TH WAY SE DECISION MADE: 12-FEB-13 ARVADA CO 80004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRANSFERRIN KIT FOR USE ON THE SPAPLUS THE BINDING SITE GROUP LTD 510(k) NO: K120236(TRADITIONAL) ATTN: JILL CONSTANTINE PHONE NO : 440 121 4569500 8 CALTHORPE ROAD EDGBASTON SE DECISION MADE: 13-FEB-13 BIRMINGHAM, WEST MIDLANDS UK B1510(k) STATEMENT DEVICE: DOSE TRACKING SYSTEM MODEL XIDF-DTS801 TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K123097(TRADITIONAL) ATTN: PAUL BIGGINS PHONE NO : 714 669 7808 2441 Michelle Dr SE DECISION MADE: 13-FEB-13 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RANGE SPINAL SYSTEM, SMALL STRATURE COMPONENTS K2M, INC. 510(k) NO: K123412(SPECIAL) ATTN: NANCY GIEZEN PHONE NO : 703 777 3155 751 MILLER DR., S.E., SUITE F1 SE DECISION MADE: 13-FEB-13 Leesburg VA 20175 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRASOUND SCANNER FLEX FOCUS B-K MEDICAL APS 510(k) NO: K123254(TRADITIONAL) ATTN: RANDI HAUERBERG PHONE NO : 011 45 44528100 MILEPARKEN 34 SE DECISION MADE: 13-FEB-13 HERLEV DA DK-2730 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM MEDTRONIC NEUROSURGERY 510(k) NO: K123524(TRADITIONAL) ATTN: DONOVAN MAY PHONE NO : 805 571 8578 125 CREMONA DR. SE DECISION MADE: 13-FEB-13 GOLETA CA 93117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTEGRA PROXIMAL HUMERAL PLATE SYSTEM ASCENSION ORTHOPEDICS, INC. 510(k) NO: K121826(TRADITIONAL) ATTN: SUSAN WALTON PHONE NO : 512 836 5001 8700 CAMERON RD SE DECISION MADE: 13-FEB-13 AUSTIN TX 78754 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: A200 KNEE SYSTEM RENOVIS SURGICAL TECHNOLOGIES, LLC510(k) NO: K120038(TRADITIONAL) ATTN: KEVIN A THOMAS PHONE NO : 858 792 1235 11234 EL CAMINO REAL SUITE 200 SE DECISION MADE: 14-FEB-13 SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MM HUIZHOU FORYOU MEDICAL DEVICES CO,510(k) NO: K120181(TRADITIONAL) ATTN: CHENGYU SHEN PHONE NO : 608 217 9358 5 CAREY STREET SE DECISION MADE: 14-FEB-13 PENNINGTON NJ 08534 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MALE LATEX CONDOM NULATEX SDN. BHD. 510(k) NO: K121241(ABBREVIATED) ATTN: TEO AI SIANG PHONE NO : 607 777 1801 LOT 1870, 4TH MLE MENGKIBOL SE DECISION MADE: 14-FEB-13 KLUANG MY 86000 510(k) STATEMENT DEVICE: ACON BUP ONE STEP BUPRENORPHINE TEST STRIP GUANGZHOU WONDFO BIOTECH CO., LTD.510(k) NO: K130055(TRADITIONAL) ATTN: JOE SHIA PHONE NO : 240 505 7880 504 EAST DIAMOND AVE. SUITE F SE DECISION MADE: 14-FEB-13 GAITHERSBURG MD 20878 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS HMD BIOMEDICAL, INC. 510(k) NO: K121433(TRADITIONAL) ATTN: JESSICA TUNG PHONE NO : 886 360170 00 #181 MINSHENG STREET SE DECISION MADE: 14-FEB-13 XINPU TOWNSHIP, HSINCHU COUNTY 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VASHE WOUND THERAPY SOLUTION PURICORE, INC. 510(k) NO: K123072(TRADITIONAL) ATTN: ART MORSE PHONE NO : 484 321 2728 508 LAPP ROAD SE DECISION MADE: 14-FEB-13 MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM11 SERIES GRANDWAY TECHNOLOGY (SHENZHEN) LIM510(k) NO: K120675(TRADITIONAL) ATTN: PATRICK CHOW PHONE NO : 008 522 8516278 ZHU KENG INDUSTRIAL ZONE PING SHANSE DECISION MADE: 14-FEB-13 SHENSHEN, GUANG DONG CH 518118 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLUCOSE METER-CHECK SOLUTION FOR ROCHE ACCU-CHEK BIONOSTICS, INC. 510(k) NO: K123851(TRADITIONAL) ATTN: RANDY BYRD PHONE NO : 978 862 1830 7 JACKSON RD. SE DECISION MADE: 14-FEB-13 DEVENS MA 01434 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT ARTHROCARE CORPORATION 510(k) NO: K123240(TRADITIONAL) ATTN: CHERYL FREDERICK PHONE NO : 512 358 5751 7000 W William Cannon Dr SE DECISION MADE: 14-FEB-13 Austin TX 78735 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ILLICO MIS POSTERIOR FIXATION SYSTEM ALPHATEC SPINE, INC. 510(k) NO: K123623(TRADITIONAL) ATTN: NADINE SMITH PHONE NO : 760 494 6717 5818 EL CAMINO REAL SE DECISION MADE: 14-FEB-13 CARLSBAD CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: A5 ANESTHESIA DELIVERY SYSTEM DATASCOPE CORP., PATIENT MONITORIN510(k) NO: K123211(ABBREVIATED) ATTN: RUSSELL OLSEN PHONE NO : 201 995 8391 800 MACARTHUR BLVD. SE DECISION MADE: 14-FEB-13 MAHWAH NJ 07430 0619 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIFESTYLES NATURAL PERSONAL LUBRICANT ANSELL HEALTHCARE PRODUCTS, LLC 510(k) NO: K122054(TRADITIONAL) ATTN: DONNA DIGANGI PHONE NO : 805 541 3344 4 LOS VERDES DRIVE SE DECISION MADE: 14-FEB-13 SAN LUIS OBISPO CA 93401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECG CHECK CARDIAC DESIGNS, LLC 510(k) NO: K122184(TRADITIONAL) ATTN: KARIM MARROUCHE PHONE NO : 512 852 2453 3293 NIBLICK DRIVE SE DECISION MADE: 14-FEB-13 PARK CITY UT 84098 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRIATHLON ALL-POLYETHYLENE CONDYLAR STABILIZING (CS) TIBIAL IMPLANTS TRIATHLON ALL-POLYETHYLENE POSTERIOR STABILIZING (P HOWMEDICA OSTEONICS CORP 510(k) NO: K123166(TRADITIONAL) ATTN: AUDREY WITKO PHONE NO : 201 831 6717 325 CORPORATE DR. SE DECISION MADE: 14-FEB-13 MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ISO-GARD CLEARAIR MASK TELEFLEX MEDICAL, INC. 510(k) NO: K123176(TRADITIONAL) ATTN: ANGELA BOUSE PHONE NO : 919 433 4904 2917 WECK DR. PO BOX 12600 SE DECISION MADE: 14-FEB-13 RESEARCH TRIANGLE PARK NC 27709 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EQUAFLOW MULTIVALVE INFUSION CATHETER COOK INCORPORATED 510(k) NO: K123235(TRADITIONAL) ATTN: AMBER BROWN PHONE NO : 812 339 2235 750 DANIELS WAY SE DECISION MADE: 14-FEB-13 BLOOMINGTON IN 47404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITRO MOLAR DFL INDUSTRIA E COMERCIO S.A. 510(k) NO: K123826(TRADITIONAL) ATTN: TARA CONRAD PHONE NO : 305 206 6777 18851 NE 29TH AVE 720 SE DECISION MADE: 14-FEB-13 AVENTURE FL 33180 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MONOJECT 12ML SYRINGE NIPRO MEDICAL CORPORATION 510(k) NO: K130049(SPECIAL) ATTN: JESSICA OSWALD-MCLEOD PHONE NO : 305 599 7174 3150 N.W. 107TH AVE. SE DECISION MADE: 14-FEB-13 MIAMI FL 33172 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV EXACT MEDICAL MANUFACTURING, INC 510(k) NO: K121919(TRADITIONAL) ATTN: ROBERT O DEAN PHONE NO : 716 440 7362 1083 DELAWARE AVE SE DECISION MADE: 14-FEB-13 BUFFALO NY 14209 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATE SYSTEM ZIMMER, INC. 510(k) NO: K123918(TRADITIONAL) ATTN: STEPHEN H MCKELVEY, MA, RAC PHONE NO : 574 372 4944 345 EAST MAIN ST. SE DECISION MADE: 14-FEB-13 WARSAW IN 46580 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM15 SERIES GRANDWAY TECHNOLOGY (SHENZHEN) LIM510(k) NO: K120673(TRADITIONAL) ATTN: PATRICK CHOW PHONE NO : 008 522 8516789 Building 6 and 7, Zhu Keng IndustrSE DECISION MADE: 14-FEB-13 Shenzhen CN 518118 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONNECT FOR DA VINCI SURGICAL SYSTEM(S) INTUITIVE SURGICAL, INC. 510(k) NO: K123840(SPECIAL) ATTN: CHERECE L JONES PHONE NO : 408 523 6925 1266 KIFER ROAD SE DECISION MADE: 14-FEB-13 SUNNYVALE CA 94086 5206 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CIRCUFLOW 5208 SEQUENTIAL COMPRESSION DEVICE DEVON MEDICAL INC. 510(k) NO: K123647(TRADITIONAL) ATTN: RUTH WU PHONE NO : 610 757 4103 1100 1ST AVENUE SUITE 100 SE DECISION MADE: 14-FEB-13 KING OF PRUSSIA PA 19406 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: GEISTLICH BIO-OSS, GEISTLICH BIO-OSS COLLAGEN, GEISTLICH COMBI-KIT COLLAGEN, GEISTLICH PERIO SYSTEM COMBI PACK, GEISTLIC GEISTLICH PHARMA AG 510(k) NO: K122894(TRADITIONAL) ATTN: DANIEL A KRACOV PHONE NO : 202 942 5120 555 TWELFTH STREET, NW SE DECISION MADE: 15-FEB-13 WASHINGTON DC 20004 1206 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CPI RAD VISION COMMUNICATIONS & POWER INDUSTRIES 510(k) NO: K122726(TRADITIONAL) ATTN: NORM MORIKAWA PHONE NO : 905 877 0161 45 RIVER DRIVE SE DECISION MADE: 15-FEB-13 GEORGETOWN,ONTARIO CA L7G 2J4 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 2008 HEMODIALYSIS SORBENT SYSTEM RENAL SOLUTIONS, INC. 510(k) NO: K123835(SPECIAL) ATTN: DAVID VANELLA PHONE NO : 724 720 2840 770 COMMONWEALTH DR. SE DECISION MADE: 15-FEB-13 WARRENDALE PA 15086 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEM ABAXIS, INC. 510(k) NO: K130200(TRADITIONAL) ATTN: DENNIS M BLEILE, PHD PHONE NO : 510 675 6515 3240 WHIPPLE RD. SE DECISION MADE: 15-FEB-13 UNION CITY CA 94587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIMENSION CHEMISTRY III CALIBRATORY SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K123321(TRADITIONAL) ATTN: ROSE T MARINELLI PHONE NO : 302 631 8805 500 GBC DRIVE MS 514 SE DECISION MADE: 15-FEB-13 NEWARK DE 19702 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIMENSION AMMONIA FLEX REAGENT CARTRIDGE SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K123320(TRADITIONAL) ATTN: ROSE T MARINELLI PHONE NO : 302 631 8805 MS 514, PO BOX 6101 SE DECISION MADE: 15-FEB-13 NEWARK DE 19714 6101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVEL ELITECHGROUP 510(k) NO: K122177(ABBREVIATED) ATTN: DEBRA K HUTSON PHONE NO : 425 482 5174 21720 23RD DR SE SUITE 150 SE DECISION MADE: 15-FEB-13 BOTHELL WA 98021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNSTER (CERVICAL,ALIF, PLIF, PTLIF AND TLIF) CAGE HERA CERVICAL CAGE RHEA PLIF CAGE TALON TIFA CAGE BM KOREA CO., LTD. 510(k) NO: K122518(SPECIAL) ATTN: PRISCILLA CHUNG PHONE NO : 714 869 3080 951 STARBUCK ST. UNIT J SE DECISION MADE: 15-FEB-13 FULLERTON CA 92833 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM SPINEFRONTIER, INC. 510(k) NO: K123164(TRADITIONAL) ATTN: FREDY H VARELA PHONE NO : 978 232 3990 500 CUMMINGS CENTER SUITE 3500 SE DECISION MADE: 15-FEB-13 BEVERLY MA 01915 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRANSCRANIAL DOPPLER WITH ROBOTIC PROBE HEADBAND SHENZHEN DELICATE ELECTRONICS CO.,510(k) NO: K122710(SPECIAL) ATTN: DIANA HONG PHONE NO : 862 122 815850 P.O. BOX 237-023 SE DECISION MADE: 15-FEB-13 SHANGHAI CH 200237 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GRIDLOCK PLATING SYSTEM TRILLIANT SURGICAL LTD 510(k) NO: K123525(SPECIAL) ATTN: J.D. WEBB PHONE NO : 512 388 0199 1001 OAKWOOD BLVD SE DECISION MADE: 15-FEB-13 ROUND ROCK TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS 25-OH VITAMIN D TOTAL REAGENT PACK, VITAMIN D TOTAL CALIBRATORS ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K121608(TRADITIONAL) ATTN: ERIC SCHAEFFER PHONE NO : 585 453 3558 100 INDIGO CREEK DR. SE DECISION MADE: 15-FEB-13 ROCHESTER NY 14626 5101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FRESHKON 1-DAY ALLURING EYES (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR FRESHKON 1-DAY MOSAIC (ETAFILC OCULUS PRIVATE LIMITED 510(k) NO: K122315(TRADITIONAL) ATTN: KEVIN WALLS PHONE NO : 720 962 5412 33 GOLDEN EAGLE LANE SE DECISION MADE: 15-FEB-13 LITTLETON CO 80127 510(k) STATEMENT DEVICE: POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE AND WHITE COLORED, NON-STERILE WEAR SAFE (MALAYSIA) SDN BHD - FAC510(k) NO: K123469(TRADITIONAL) ATTN: ALEX YOONG PHONE NO : 603 339 36088 LOT 63616, PT 54924, NO 3, JALAN KSE DECISION MADE: 19-FEB-13 MUKIM KAPAR, KLANG, SELANGOR MY510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIFESTYLES LUXE PREMIUM PERSONAL LUBRICANT ANSELL HEALTHCARE PRODUCTS LLC 510(k) NO: K122477(TRADITIONAL) ATTN: DONNA DIGANGI PHONE NO : 805 541 3344 4 LOS VERDES DRIVE SE DECISION MADE: 19-FEB-13 SAN LUIS OBISPO CA 93401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEXUS RMGI KERR CORPORATION 510(k) NO: K123595(TRADITIONAL) ATTN: COLLEEN BOSWELL PHONE NO : 714 516 7484 1717 WEST COLLINS AVENUE SE DECISION MADE: 19-FEB-13 ORANGE CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMMUNIFY PACS VIEWER COMMUNIFY HEALTH, LLC 510(k) NO: K120851(TRADITIONAL) ATTN: CHRIS RELYEA PHONE NO : 646 526 7111 160W 71ST 18 FLOOR SE DECISION MADE: 19-FEB-13 NEW YORK NY 10023 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTRADERMAL ADAPTER WEST PHARMACEUTICAL SERVICES, INC.510(k) NO: K123588(TRADITIONAL) ATTN: DEBBIE M THOMAS PHONE NO : 610 594 3105 101 GORDON DR. SE DECISION MADE: 19-FEB-13 LIONVILLE PA 19341 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REVOLIX JR 30, REVOLIX JR 50, REVOLIX JR 160, REVOLIX FR 200 ALLMED SYSTEMS INC. 510(k) NO: K110941(TRADITIONAL) ATTN: PETER ALLEN PHONE NO : 925 468 0433 9232 KLEMETSON DRIVE SE DECISION MADE: 19-FEB-13 PLEASANTON CA 94588 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DESARA SL CALDERA MEDICAL, INC. 510(k) NO: K121928(TRADITIONAL) ATTN: VICKI GAIL PHONE NO : 818 483 7602 5171 CLARETON DRIVE SE DECISION MADE: 19-FEB-13 AGOURA HILLS CA 91301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAMMOWORKSTATION IMAGE DIAGNOST INTERNATIONAL GMBH 510(k) NO: K123575(TRADITIONAL) ATTN: MOUNIR ZAOUALI PHONE NO : 331 307045 39 283 RUE DE LA MINIERE SE DECISION MADE: 19-FEB-13 BUC FR 78530 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTAS SYSTEM FROM RESTORATION ROBOTICS RESTORATION ROBOTICS, INC 510(k) NO: K123154(TRADITIONAL) ATTN: JIM TALBOT PHONE NO : 408 883 6888 128 BAYTECH DRIVE SE DECISION MADE: 19-FEB-13 SAN JOSE CA 95134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DA VINCI SINGLE-SITE INSTRUMENTS AND ACCESSORIES INTUITIVE SURGICAL, INC. 510(k) NO: K122532(TRADITIONAL) ATTN: MELISSA S GONZALEZ PHONE NO : 408 523 2100 1266 KIFER ROAD SE DECISION MADE: 19-FEB-13 SUNNYVALE CA 94086 5206 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARIX RAD ACQUISITION CONSOLE COMPANIA MEXICANA DE RADIOLOGIA CG510(k) NO: K123650(TRADITIONAL) ATTN: CARL ALLETTO PHONE NO : 469 684 1980 1600 MANCHESTER WAY SE DECISION MADE: 20-FEB-13 CORINTH TX 76210 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TWINFIX TI 3.5MM SUTURE ANCHOR WITH TWO ULTRABRAID SUTURE #2 WITH NEEDLES, SL SMITH & NEPHEW, INC. 510(k) NO: K123425(TRADITIONAL) ATTN: CATHERINE KILSHAW PHONE NO : 508 337 4104 150 MINUTEMAN RD. SE DECISION MADE: 20-FEB-13 ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MDU5 PLUS STERILE BAG BOSTON SCIENTIFIC CORP. 510(k) NO: K123424(TRADITIONAL) ATTN: LORI R SMITH PHONE NO : 510 624 1698 47215 LAKEVIEW BOULEVARD SE DECISION MADE: 20-FEB-13 FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNSPAR ADVANCED ARDENT INC 510(k) NO: K123613(ABBREVIATED) ATTN: DONNA M HARTNETT PHONE NO : 716 691 2260 175 Pineview Dr SE DECISION MADE: 20-FEB-13 Amherst NY 14228 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMFORT COUGH LK CONSULTING GROUP 510(k) NO: K113549(TRADITIONAL) ATTN: PRISCILLA CHUNG PHONE NO : 714 869 3080 1515 E KATELLA AVE. UNIT 2115 SE DECISION MADE: 21-FEB-13 ANAHEIM CA 92805 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COPRANCOLOR WHITE PEAKS DENTAL SYSTEMS GMBH & 510(k) NO: K123680(TRADITIONAL) ATTN: OLIVER PUCKERT PHONE NO : 492 812 0645813 LANGHEIDE 9 SE DECISION MADE: 21-FEB-13 ESSEN GM 45239 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FIN-S MICROIMPLANT CREEKSIDE ORTHODONTICS 510(k) NO: K120861(TRADITIONAL) ATTN: JOHN T KALANGE PHONE NO : 208 342 0212 136 E. MALLARD DR. SE DECISION MADE: 21-FEB-13 BOISE ID 83706 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITRO FIL LC DFL INDUSTRIA E COMERCIO S.A. 510(k) NO: K123824(TRADITIONAL) ATTN: TARA CONRAD PHONE NO : 305 206 6777 18851 NE 29TH AVE 720 SE DECISION MADE: 21-FEB-13 AVENTURE FL 33180 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CM CALDERA MEDICAL 510(k) NO: K123337(TRADITIONAL) ATTN: VICKI GAIL PHONE NO : 818 483 7602 5171 Clareton Dr SE DECISION MADE: 21-FEB-13 Agoura Hills CA 91301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERCUTANEOUS INTRODUCER KIT TELEFLEX, INC. 510(k) NO: K123974(TRADITIONAL) ATTN: DAWN L MOORE PHONE NO : 603 532 7706 50 PLANTATION DR. SE DECISION MADE: 21-FEB-13 JAFFREY NH 03452 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DAILIES AQUACOMFORT PLUS, DAILIES AQUACOMFORT PLUS TORIC, DAILIES AQUACOMFORT PLUS MULTIFOCAL CIBA VISION CORPORATION 510(k) NO: K123994(TRADITIONAL) ATTN: MARTINA HEIM, PH.D., RAC PHONE NO : 678 415 3565 11460 JOHNS CREEK PARKWAY SE DECISION MADE: 21-FEB-13 DULUTH GA 30097 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERIFICATION CONSOLE VARIAN MEDICAL SYSTEMS 510(k) NO: K124002(TRADITIONAL) ATTN: PETER J CORONADO PHONE NO : 650 424 6320 3100 HANSEN WAY SE DECISION MADE: 21-FEB-13 PALO ALTO CA 94304 1034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CINCHLOCK KNOTLESS SUTURE ANCHOR PIVOT MEDICAL 510(k) NO: K123651(TRADITIONAL) ATTN: JON COOK PHONE NO : 408 774 1452 247 HUMBOLDT CT. SE DECISION MADE: 21-FEB-13 SUNNYVALE CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FIBER DISK AND BLOCK PERMANENT, TRINIA BIOLOREN SRL 510(k) NO: K121735(TRADITIONAL) ATTN: RATTI ANDREA PHONE NO : 39 02 96703261 VIA ALESSANDRO VOLTA 59 SE DECISION MADE: 21-FEB-13 SARONNO, VA IT 21047 510(k) STATEMENT DEVICE: EMBLETTA MPR EMBLA SYSTEMS 510(k) NO: K122516(TRADITIONAL) ATTN: JENNIFER ARMSTRONG PHONE NO : 613 254 8877 1 HINES RD STE 202 SE DECISION MADE: 21-FEB-13 KANATA CA K2K 3C7 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LUCENT SPINAL ELEMENTS, INC. 510(k) NO: K122967(SPECIAL) ATTN: BENJAMIN A KIMBALL PHONE NO : 760 607 1816 2744 LOKER AVE. W. SUITE 100 SE DECISION MADE: 21-FEB-13 CARLSBAD CA 92010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PEKKTON IVORY CENDRES & METAUX SA 510(k) NO: K123638(TRADITIONAL) ATTN: T. BONGNI PHONE NO : 415 836 02302 RUE DE BOUJEAN 122 SE DECISION MADE: 21-FEB-13 BIEL/BIENNE SZ 2501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE HL RUBBER INDUSTRIES SDN BHD 510(k) NO: K130038(TRADITIONAL) ATTN: NOORZALIZA AHMAD PHONE NO : 606 481408 788 LOT 10, KAWASAN PERINDUSTRIAN DIOHSE DECISION MADE: 21-FEB-13 KUALA PILAH, NEGERI SEMBILAN MY510(k) STATEMENT DEVICE: MEDICAL GORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM MEDICALGORITHMICS S.A. 510(k) NO: K124060(ABBREVIATED) ATTN: MARTIN JASINSKI PHONE NO : 917 941 9581 245 WEST 107TH ST. SUITE 11A SE DECISION MADE: 21-FEB-13 NEW YORK NY 10025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DETACHATIP III PLUS INSTRUMENT TRAY MODEL 3-4343 CONMED CORPORATION 510(k) NO: K123175(ABBREVIATED) ATTN: ANNA D'LIMA PHONE NO : 315 624 3439 525 FRENCH RD. SE DECISION MADE: 21-FEB-13 UTICA NY 13502 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MRI PATIENT MONITORING SYSTEM (MODEL 865214) INVIVO CORPORATION 510(k) NO: K124061(SPECIAL) ATTN: RUSTY KELLY PHONE NO : 407 455 6166 12151 RESEARCH PKWY SE DECISION MADE: 22-FEB-13 ORLANDO FL 32826 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: BLUE STERILE POWDER FREE NITRILE EXAMINATION GLOVE NORTHSTAR HEALTHCARE HOLDINGS 510(k) NO: K122727(ABBREVIATED) ATTN: MICHAEL RIORDAN PHONE NO : 353 214548 255 70 SIR JOHN ROGERSONS QUAY SE DECISION MADE: 22-FEB-13 DUBLIN 2 IE -- 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ZIMMER PERSONA TM PERSONALIZED KNEE SYSTEM ZIMMER INC. 510(k) NO: K123459(TRADITIONAL) ATTN: CAROL VIERLING, RAC PHONE NO : 574 372 4964 P.O. BOX 708 SE DECISION MADE: 22-FEB-13 WARSAW IN 46581 0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMORY CARDIAC TOOLBOX 4.0 SYNTERMED, INC. 510(k) NO: K123646(TRADITIONAL) ATTN: KENNETH VAN TRAIN PHONE NO : 888 263 4446 245 OWENS DR. SE DECISION MADE: 22-FEB-13 ANAHEIM CA 92808 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SILKN BLUE HOME SKINOVATIONS LTD. 510(k) NO: K121435(TRADITIONAL) ATTN: AMIR WALDMAN PHONE NO : 972 547404 616 TAVOR BULD. POB 533 SE DECISION MADE: 22-FEB-13 YOKNEAM ILLIT IS 20692 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VPULSE COTHERA, LLC 510(k) NO: K122640(TRADITIONAL) ATTN: JUSTIN EGGLETON PHONE NO : 202 552 5800 1331 H STREET NW 12TH FLOOR SE DECISION MADE: 22-FEB-13 WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAMMOMAL INSPIRATION SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K122286(TRADITIONAL) ATTN: PATRICIA D JONES PHONE NO : 610 448 3536 51 VALLEY STREAM PKWY. SE DECISION MADE: 22-FEB-13 MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIFESTYLES WARM LOVIN PERSONAL LUBRICANT ANSELL HEALTHCARE PRODUCTS LLC 510(k) NO: K122720(TRADITIONAL) ATTN: DONNA DI GANGI PHONE NO : 805 541 3344 4 LOS VERDES DRIVE SE DECISION MADE: 22-FEB-13 SAN LUIS OBISPO CA 93401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IRIS - HIGH STRENGTH GLASS CERAMIC DENTSPLY INTL. 510(k) NO: K123615(TRADITIONAL) ATTN: HELEN LEWIS PHONE NO : 717 849 4229 21 W PHILADEPHIA STREET SUITE 60W SE DECISION MADE: 22-FEB-13 YORK PA 17405 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOSCOPIC ULTRASOUND CENTER EU-Y0008 OLYMPUS MEDICAL SYSTEMS CORP. 510(k) NO: K130058(TRADITIONAL) ATTN: DAPHNEY GERMAIN-KOLAWOLE PHONE NO : 484 896 5691 REGULATORY AFFAIRS & QUALITY ASSURSE DECISION MADE: 22-FEB-13 CENTER VALLEY PA 18034 0610 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: U-MOTION II ACETABULAR SYSTEM UNITED ORTHOPEDIC CORP. 510(k) NO: K122185(TRADITIONAL) ATTN: FANG-YUAN HO PHONE NO : 886 357 73351X2212 57 PARK AVE. 2, SCIENCE PARK SE DECISION MADE: 22-FEB-13 HSINCHU TW 300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MYVISIONTRACK(TM) VITAL ART AND SCIENCE INCORPORATED510(k) NO: K121738(TRADITIONAL) ATTN: MICHAEL BARTLETT PHONE NO : 214 989 7130 2725 N. SPRING DR. SE DECISION MADE: 22-FEB-13 RICHARDSON TX 75082 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERSONA NATURAL TIBIA BASEPLATES ZIMMER, INC. 510(k) NO: K130143(SPECIAL) ATTN: NICOLE J MEREDITH PHONE NO : 574 372 4517 P.O. BOX 708 SE DECISION MADE: 22-FEB-13 WARSAW IN 46581 0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTOS OCT/SLO MICROPERIMETER OPTOS PLC 510(k) NO: K121043(TRADITIONAL) ATTN: RANDY J PREBULA PHONE NO : 202 637 6548 555 THIRTEENTH ST. N.W. SE DECISION MADE: 22-FEB-13 WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INCLUSIVE TAPERED IMPLANT SYSTEM PRISMATIK DENTALCRAFT, INC. 510(k) NO: K121406(TRADITIONAL) ATTN: ARMIN ZEHTABCHI PHONE NO : 949 399 1940 2212 DUPONT DR., ST P SE DECISION MADE: 22-FEB-13 IRVINE CA 92612 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZI BLOWER DESHUM MEDICAL 510(k) NO: K121374(TRADITIONAL) ATTN: MAUREEN O'CONNELL PHONE NO : 978 207 1245 5 TIMBER LANE SE DECISION MADE: 22-FEB-13 NORTH READING MA 01864 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE HOWMEDICA OSTEONICS CORP. 510(k) NO: K122015(TRADITIONAL) ATTN: CHRISTIE PENCINGER PHONE NO : 201 831 6365 325 CORPORATE DR SE DECISION MADE: 22-FEB-13 MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT CYTOPHIL INC 510(k) NO: K121795(TRADITIONAL) ATTN: BILL HUBBARD PHONE NO : 262 642 2765 2485 CORPORATE CIRCLE SUITE 2 SE DECISION MADE: 22-FEB-13 EAST TROY WI 53120 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: T:CONNECT DATA MANAGEMENT SYSTEM TANDEM DIABETES CARE, INC. 510(k) NO: K122361(TRADITIONAL) ATTN: DON CANAL PHONE NO : 858 366 6963 11045 Roselle St Ste 200 SE DECISION MADE: 22-FEB-13 San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 1.5T 4CH LARGE FLEX COIL, 1.5 4CH SMALL FLEX COIL WIPRO GE HEALTHCARE PRIVATE, LTD. 510(k) NO: K123681(TRADITIONAL) ATTN: SHASHIDHAR C S PHONE NO : 91 988 6799814 122 (PART 1) JOHN F WELCH TRDNG CESE DECISION MADE: 22-FEB-13 BANGALORE IN 560066 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RETROGRADE CORONARY SINUS CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CANNULA EDWARDS LIFESCIENCES, LLC. 510(k) NO: K123187(TRADITIONAL) ATTN: KAREN JONES PHONE NO : 801 565 6231 12050 LONE PEAK PKWY SE DECISION MADE: 22-FEB-13 DRAPER UT 84020 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EOS EOS IMAGING 510(k) NO: K123740(SPECIAL) ATTN: JOHN J SMITH PHONE NO : 202 637 3638 555 THIRTEENTH STREET, NW SE DECISION MADE: 22-FEB-13 WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K123809(SPECIAL) ATTN: SOWMYA SHETTY PHONE NO : 901 396 3133 1800 PYRAMID PLACE SE DECISION MADE: 22-FEB-13 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K123656(TRADITIONAL) ATTN: CLAIRE EVANS PHONE NO : 901 396 3133 1800 PYRAMID PLACE SE DECISION MADE: 25-FEB-13 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACHILLES GE MEDICAL SYSTEMS CHINA CO., LTD.510(k) NO: K123238(TRADITIONAL) ATTN: LIU ZHAO PHONE NO : 86 510 85278028 NO. 19 CHANGJIANG ROAD NATIONAL HISE DECISION MADE: 25-FEB-13 WUXI, JIANGSU PROVINCE CH 21402510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITREA CT TRANSCATHETER AORTIC VALVE REPLACMENT (TAVR) PLANNING VITAL IMAGES, INC. 510(k) NO: K122578(TRADITIONAL) ATTN: IAN NEMEROV PHONE NO : 952 487 9622 5850 Opus Pkwy Ste 300 SE DECISION MADE: 25-FEB-13 MINNETONKA MN 55343 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE ARTAS SYSTEM RESTORATION ROBOTICS, INC 510(k) NO: K123548(TRADITIONAL) ATTN: JIM TALBOT PHONE NO : 408 883 6760 128 BAYTECH DRIVE SE DECISION MADE: 25-FEB-13 SAN JOSE CA 95134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM BIOMET SPINE (AKA EBI, LLC) 510(k) NO: K123549(TRADITIONAL) ATTN: VIVIAN KELLY, MS, RAC PHONE NO : 973 299 9300 100 INTERPACE PARKWAY SE DECISION MADE: 25-FEB-13 PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA INOVA DIAGNOSTICS, INC. 510(k) NO: K120817(TRADITIONAL) ATTN: ROSANNA KEIVENS PHONE NO : 858 586 9900 9900 OLD GROVE RD. SE DECISION MADE: 26-FEB-13 SAN DIEGO CA 92131 1638 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTAVI HYDROPHILIC GUIDEWIRE LAKE REGION MEDICAL 510(k) NO: K124052(TRADITIONAL) ATTN: TRACY MEYER PHONE NO : 952 448 5111 340 LAKE HAZELTINE DRIVE SE DECISION MADE: 26-FEB-13 CHASKA MN 55318 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHOCORD DEPUY MITEK INC., A JOHNSON AND JO510(k) NO: K123668(TRADITIONAL) ATTN: TATYANA KORSUNSKY PHONE NO : 508 828 3122 325 PARAMOUNT DRIVE SE DECISION MADE: 26-FEB-13 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEINE OMEGA 500 HEINE OPTOTECHNIK GMBH & CO. KG. 510(k) NO: K123316(ABBREVIATED) ATTN: JORG RONNAU PHONE NO : 49 815 2380 KIENTALSTRASSE 7 SE DECISION MADE: 26-FEB-13 HERRSCHING GM D-82211 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: BRIDGE EXTRACELLULAR COLLEGEN MATRIX HARBOR MEDTECH, INC. 510(k) NO: K122502(TRADITIONAL) ATTN: JERRY MEZGER PHONE NO : 949 679 4800 4 JENNER SUITE 190 SE DECISION MADE: 26-FEB-13 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K123529(TRADITIONAL) ATTN: PATRICIA D JONES PHONE NO : 610 448 3536 51 VALLEY STREAM PKWY. SE DECISION MADE: 26-FEB-13 MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITAL 5 RELEAF CATHETER VITAL 5 510(k) NO: K122661(TRADITIONAL) ATTN: T. WADE FALLIN PHONE NO : 435 752 0307 570 RESEARCH PARK WAY SUITE 102 SE DECISION MADE: 27-FEB-13 NORTH LOGAN UT 84341 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - P55 BECTON, DICKINSON AND COMPANY 510(k) NO: K130197(SPECIAL) ATTN: JOHN ROBERTS PHONE NO : 201 847 5473 1 BECTON DRIVE MC237 SE DECISION MADE: 27-FEB-13 FRANKLIN LAKES NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITAL SYNC SYSTEM COVIDIEN, FORMERLY NELLCOR PURITAN510(k) NO: K123002(TRADITIONAL) ATTN: KELSEY LEE PHONE NO : 303 305 2760 6135 Gunbarrel Ave SE DECISION MADE: 27-FEB-13 BOULDER CO 80301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, PATHFINDER OBTURATOR & SHARP TIPPED OBTURATOR, LOW PROFILE DR ARTHROCARE CORP. 510(k) NO: K130196(SPECIAL) ATTN: LAURA KASPEROWICZ PHONE NO : 949 585 2406 15285 ALTON PARKWAY, No. 200 SE DECISION MADE: 27-FEB-13 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSS MODULAR STEMS, OSS DIAPHYSEAL SEGMENTS BIOMET, INC. 510(k) NO: K123501(SPECIAL) ATTN: GARY BAKER PHONE NO : 574 267 6639 56 EAST BELL DR. SE DECISION MADE: 27-FEB-13 WARSAW IN 46581 0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PICCOLO COMPOSITE PLATE SYSTEM CARBOFIX ORTHOPEDICS LTD. 510(k) NO: K130061(SPECIAL) ATTN: YAEL RUBIN PHONE NO : 972 9 9511511 11 HA'HOSHLIM STREET SE DECISION MADE: 27-FEB-13 HERZELIYA IS 46724 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DANA REUSABLE BOWIE TEST PACK FOR DANA BOWIE DICK INDICATORS DANA PRODUCTS, INC. 510(k) NO: K120592(TRADITIONAL) ATTN: HARRY BALA PHONE NO : 847 455 2881 7 COREY DR. SE DECISION MADE: 27-FEB-13 SOUTH BARINGTON IL 60010 510(k) STATEMENT DEVICE: QUATTRO AIR RESMED LTD. 510(k) NO: K123979(TRADITIONAL) ATTN: JIM CASSI PHONE NO : 858 836 6081 9001 SPECTRUM CENTER BLVD. SE DECISION MADE: 27-FEB-13 SAN DIEGO CA 92123 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIMMETRY SACROILIAC JOINT FUSION SYSTEM ZYGA TECHNOLOGY, INC. 510(k) NO: K130092(SPECIAL) ATTN: DIANE BRINZA PHONE NO : 612 455 1061 700 10TH AVE SOUTH, STE 20 SE DECISION MADE: 27-FEB-13 MINNEAPOLIS MN 55415 1745 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ESOTEST ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM FIAB SPA 510(k) NO: K123361(TRADITIONAL) ATTN: FRANCESCO BATISTINI PHONE NO : 39 055 84979243 VIA COSTOLI, 4 VICCHIO SE DECISION MADE: 27-FEB-13 FIRENZE IT 50039 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIODESIGN ENT REPAIR GRAFT COOK BIOTECH INCORPRATED 510(k) NO: K121360(TRADITIONAL) ATTN: MARY A FADERAN, PH.D., RAC PHONE NO : 765 497 3355 1425 INNOVATION PLACE SE DECISION MADE: 27-FEB-13 WEST LAFAYETTE IN 47906 1000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INION FREEDOMSCREW (ALTERNATIVE MARKETING NAME: INION OTPS FREEDOMSCREW) INION OY 510(k) NO: K123672(TRADITIONAL) ATTN: KATI MARTTINEN PHONE NO : 358 108 306611 LAAKARINKATU 2 SE DECISION MADE: 27-FEB-13 TAMPERE FI 33520 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INMODE HAIR REMOVAL (HR) DEVICE INMODE MD LTD. 510(k) NO: K123682(TRADITIONAL) ATTN: AHAVA STEIN PHONE NO : 972 9 7670002 20 HATA'AS STR., SUITE 102 SE DECISION MADE: 27-FEB-13 KFAR SABA IS 44425 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL ELECTROCARDIOGRAPHS SHENZHEN BIOCARE ELECTRONICS CO., 510(k) NO: K123816(SPECIAL) ATTN: DIANA HONG PHONE NO : 86 21 22815850 P.O. BOX 237-023 SE DECISION MADE: 27-FEB-13 SHANGHAI CH 200237 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES GE HEALTHCARE FINLAND OY 510(k) NO: K123195(TRADITIONAL) ATTN: RAUNO RUOHO PHONE NO : 358 103941 1 KUORTANEENKATU 2 SE DECISION MADE: 28-FEB-13 HELSINKI FI FIN-00510 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CIRCUFLOW 5150 DEVON MEDICAL INC. 510(k) NO: K123959(TRADITIONAL) ATTN: RUTH WU PHONE NO : 610 757 4103 1100 1ST AVENUE SUITE 100 SE DECISION MADE: 28-FEB-13 KING OF PRUSSIA PA 19406 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ANKLE TRAUMA SYSTEM ORTHOPRO LLC 510(k) NO: K122936(TRADITIONAL) ATTN: BROCK JOHNSON PHONE NO : 801 746 0208 3450 Highland Dr Ste 303 SE DECISION MADE: 28-FEB-13 Millcreek UT 84106 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3M TEGADERM CHG CHLORHEXIDINE GLUCONATE I.V. PORT DRESSING 3M COMPANY 510(k) NO: K123679(TRADITIONAL) ATTN: JOANN HUEHN PHONE NO : 651 733 9209 3M CENTER, 2510 CONWAY AVE. BLDG. SE DECISION MADE: 28-FEB-13 ST. PAUL MN 55144 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FACET SCREW SYSTEM FACET-LINK, INC. 510(k) NO: K123497(TRADITIONAL) ATTN: JANICE M HOGAN PHONE NO : 267 675 4611 1835 MARKET ST. 29TH FLOOR SE DECISION MADE: 28-FEB-13 PHILADELPHIA PA 19103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES DEHAI (SHANDONG) MEDICAL GLOVES, C510(k) NO: K123869(TRADITIONAL) ATTN: RAY ZHOU PHONE NO : 909 548 4828 12390 EAST END AVE. SE DECISION MADE: 28-FEB-13 CHINO CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COBAS INTEGRA BILIRUBIN DIRECT GEN.2 ROCHE DIAGNOSTICS 510(k) NO: K123965(TRADITIONAL) ATTN: SUSAN HOLLANDBECK PHONE NO : 317 521 3380 9115 SOUTH HAGUE ROAD SE DECISION MADE: 28-FEB-13 INDIANAPOLIS IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEAR ALIGNER ADHESIVE RELIANCE ORTHODONTIC PRODUCTS, INC510(k) NO: K123348(TRADITIONAL) ATTN: PAULA WENDLAND PHONE NO : 630 773 4009 1540 WEST THORNDALE AVE. SE DECISION MADE: 28-FEB-13 ITASCA IL 60143 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DURABLUE STERILIZATION WRAP CARDINAL HEALTH-MEDICAL PRODUCTS A510(k) NO: K123289(TRADITIONAL) ATTN: LAVENIA FORD PHONE NO : 847 887 3323 1430 WAUKEGAN RD. SE DECISION MADE: 28-FEB-13 MCGAW PARK IL 60085 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MARK 5 NUVO LITE OCSI, MARK 5 NUVO LITE STD NIDEK MEDICAL PRODUCTS, INC. 510(k) NO: K123738(SPECIAL) ATTN: VAN MUTH PHONE NO : 205 856 7200 3949 VALLEY EAST INDUSTRIAL DR SE DECISION MADE: 28-FEB-13 BIRMINGHAM AL 35217 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALIGHT 16 SUPERSELECTIVE MICROWIRE GUIDE COOK, INC. 510(k) NO: K123707(SPECIAL) ATTN: DAVID LEHR PHONE NO : 812 339 2235 750 DANIELS WAY SE DECISION MADE: 28-FEB-13 BLOOMINGTON IN 47404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN SURGICAL SPECIALTIES CORP. DBA ANG510(k) NO: K130078(TRADITIONAL) ATTN: KIRSTEN STOWELL PHONE NO : 610 404 3367 100 DENNIS DR. SE DECISION MADE: 28-FEB-13 Reading PA 19606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES PATIENT SPECIFIC PLATE SYNTHES INC 510(k) NO: K122647(TRADITIONAL) ATTN: ALAN T HALEY PHONE NO : 484 356 9763 1301 GOSHEN PARKWAY SE DECISION MADE: 28-FEB-13 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTERVERTEBRAL BODY FUSION DEVICE DIO MEDICAL CO., LTD. 510(k) NO: K122872(TRADITIONAL) ATTN: APRIL LEE PHONE NO : 714 525 0114 325 N. PUENTE ST UNIT B SE DECISION MADE: 28-FEB-13 BREA CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LOFRIC SENSE WELLSPECT HEALTHCARE 510(k) NO: K123751(TRADITIONAL) ATTN: ALLISON C KOMIYAMA PHONE NO : 858 792 1235 12264 EL CAMINO REAL SUITE 400 SE DECISION MADE: 28-FEB-13 SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: U-RIGHT COMPRESSOR NEBULIZER TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K121969(TRADITIONAL) ATTN: PINJUNG CHEN PHONE NO : 886 266 258188 3F,5F, No.127, Wugong 2nd Rd. WuguSE DECISION MADE: 28-FEB-13 New Taipei City TW 24888 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GENERAL PURPOSE TEMPERATURE PROBE, SKIN TEMPERATURE PROBE DRAEGER MEDICAL GMBH 510(k) NO: K121999(TRADITIONAL) ATTN: BETH ZIS PHONE NO : 978 379 8265 6 TECH DR SE DECISION MADE: 28-FEB-13 ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TI-MAX Z45 NAKANISHI, INC. 510(k) NO: K121901(TRADITIONAL) ATTN: FUMIAKI KANAI PHONE NO : 813 381 88577 4-4-17 HONGO SE DECISION MADE: 28-FEB-13 BUNKYO-KU JA 113-0033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EDRAIN CHEST DRAINAGE SYSTEM ATRIUM MEDICAL CORP. 510(k) NO: K130131(TRADITIONAL) ATTN: CHRISTINA CALDERWOOD PHONE NO : 603 880 1433 5 Wentworth Dr SE DECISION MADE: 28-FEB-13 HUDSON NH 03051 510(k) STATEMENT TOTAL 510(k)s THIS PERIOD 243 TOTAL WITH SUMMARIES 234 TOTAL WITH STATEMENTS 9
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