Medical Devices
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September 2012 510(k) Clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD September 2012 DEVICE: ORTHOFIX GALAXY FIXATION SYSTEM ORTHOFIX SRL 510(k) NO: K113770(TRADITIONAL) ATTN: CANDACE F CEDERMAN PHONE NO : 503 722 7494 15058 ARMEL DR. SE DECISION MADE: 04-SEP-12 OREGON CITY OR 97045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TENS BACK PAIN RELIEF SYSTEM SAVIA LIMITED 510(k) NO: K113321(TRADITIONAL) ATTN: GUENTER GINSBERG PHONE NO : 239 948 2001 11820 RED HIBISCUS SE DECISION MADE: 04-SEP-12 BONITA SPRINGS FL 34135 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IOI TOTAL HIP ICONACY ORTHOPEDIC IMPLANTS, LLC 510(k) NO: K121034(TRADITIONAL) ATTN: ROY Y HORI, PHD PHONE NO : 574 269 4622 PO BOX 1033 SE DECISION MADE: 04-SEP-12 WARSAW IN 46581 1033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CVINSIGHT INTELOMED, INC 510(k) NO: K120052(TRADITIONAL) ATTN: JAN BERKOW PHONE NO : 412 213 3251 4284 LAMPL LN SE DECISION MADE: 04-SEP-12 ALLISON PARK PA 15101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM VATECH CO., LTD. 510(k) NO: K122155(SPECIAL) ATTN: DAVE KIM PHONE NO : 713 467 2607 12946 KIMBERLEY LN SE DECISION MADE: 04-SEP-12 HOUSTON TX 77079 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARC ENDOCUFF BODDINGTONS PLASTICS LTD 510(k) NO: K122565(TRADITIONAL) ATTN: JOHN BOVIS PHONE NO : 440 1622 833700 UNIT 6 WHEELBARROW PARK ESTATE PATSE DECISION MADE: 04-SEP-12 TONBRIDGE, KENT UK TN12 9QL 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES MAUNA KEA TECHNOLOGIES 510(k) NO: K122042(TRADITIONAL) ATTN: MICHAEL DANIEL PHONE NO : 415 407 0223 8 SNOWBERRY COURT SE DECISION MADE: 04-SEP-12 ORINDA CA 94563 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALAMO P ALLIANCE PARTNERS, LLC 510(k) NO: K122047(TRADITIONAL) ATTN: JENNIFER PALINCHIK PHONE NO : 440 933 8850 33490 PIN OAK PARKWAY SE DECISION MADE: 04-SEP-12 AVON LAKE OH 44012 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TEST, BLOOD GLUCOSE SYSTEM HMD BIOMEDICAL, INC. 510(k) NO: K120064(TRADITIONAL) ATTN: JESSICA TUNG PHONE NO : 886 360 17000 NO 181, MINGSHENG ST SE DECISION MADE: 05-SEP-12 XINPU TOWNSHIP, HSINCHU COUNTY 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIGASURE CURVED, SMALL JAW, OPEN SEALER/DIVIDER COVIDIEN, FORMERLY VALLEYLAB, A DI510(k) NO: K113572(TRADITIONAL) ATTN: JOHN VAN HOVEN PHONE NO : 303 476 7502 5920 LONGBOW DR. SE DECISION MADE: 05-SEP-12 BOULDER CO 80301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TIXOS IMPLANT SYSTEM LEADER ITALIA S.R.L. 510(k) NO: K120792(TRADITIONAL) ATTN: STUART R GOLDMAN PHONE NO : 512 327 9998 611 WEST 5TH ST, THIRD FLOOR SE DECISION MADE: 05-SEP-12 AUSTIN TX 78701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: METS SMILES TOTAL KNEE REPLACEMENT STANMORE IMPLANTS WORLDWIDE LTD 510(k) NO: K120992(TRADITIONAL) ATTN: NANCY C MACDONALD PHONE NO : 781 329 2993 690 CANTON STREET SUITE 302 SE DECISION MADE: 05-SEP-12 WESTWOOD MA 02090 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOHORIZONS TAPERED INTERNAL PLUS IMPLANTS BIOHORIZONS IMPLANT SYSTEMS, INC. 510(k) NO: K121787(SPECIAL) ATTN: MICHAEL DAVIS PHONE NO : 205 967 7880 2300 RIVERCHASE CENTER SE DECISION MADE: 05-SEP-12 BIRMINGHAM AL 35244 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLASH PTA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH PTA BALLOON DILATATION CATHETER - 4MM X 19MM X 135CM OSTIAL CORPORATION 510(k) NO: K122379(SPECIAL) ATTN: KAITLIN VON HOFFMANN PHONE NO : 650 903 9100 510 CLYDE AVENUE SE DECISION MADE: 05-SEP-12 MOUNTAIN VIEW CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEOSS PROACTIVE TAPERED IMPLANT NEOSS LTD 510(k) NO: K113376(TRADITIONAL) ATTN: CHERITA JAMES PHONE NO : 703 563 9800 901 KING STREET SUITE 200 SE DECISION MADE: 05-SEP-12 ALEXANDRIA VA 22314 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LOW PROFILE GASTROSTOMY FEEDING TUBE OR GASTROTOMEY BUTTON DEGANIA SILICONE, LTD. 510(k) NO: K122030(TRADITIONAL) ATTN: ZOYA LEE PHONE NO : 972 467 55122 KIBBUTZ DEGANIA BET SE DECISION MADE: 05-SEP-12 EMEK HAYARDEN IS 15130 510(k) STATEMENT DEVICE: MOLLRING MULTITASC LEMAITRE VASCULAR, INC. 510(k) NO: K121415(TRADITIONAL) ATTN: ANDREW HODGKINSON PHONE NO : 781 221 2266 63 2ND AVENUE SE DECISION MADE: 05-SEP-12 BEDFORD MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UGEO G60 DIAGNOSTIC ULTRASOUND SYSTEM SAMSUNG MEDISON CO., LTD 510(k) NO: K122583(TRADITIONAL) ATTN: PHONE NO : 42, TEHERAN-RO 108-GIL GANGNAM-GU SE DECISION MADE: 05-SEP-12 SEOUL KS 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS) MEDICAL COMPONENTS INC 510(k) NO: K121383(TRADITIONAL) ATTN: JEAN CALLOW PHONE NO : 215 256 4201 1499 DELP DRIVE SE DECISION MADE: 05-SEP-12 HARLEYSVILLE PA 19438 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RELIANCE ANTERIOR CERVICAL PLATE SYSTEM RELIANCE MEDICAL SYSTEMS, LLC 510(k) NO: K122216(TRADITIONAL) ATTN: BRET M BERRY PHONE NO : 801 294 3280 545 SOUTH 500 WEST SUITE 100 SE DECISION MADE: 05-SEP-12 BOUNTIFUL UT 84010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP. AUTO-CHECK CONTROL SOLUTION I-SENS, INC. 510(k) NO: K121654(SPECIAL) ATTN: HYUN JOON OH PHONE NO : 822 916619 1 465-6 WOLGYE-DONG, NOWON-GU SE DECISION MADE: 05-SEP-12 SEOUL KS 139-845 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TERUMO SURFLASH SAFETY I.V. CATHETER TERUMO CORPORATION 510(k) NO: K122544(TRADITIONAL) ATTN: SANDI HARTKA PHONE NO : 410 392 7231 1727-1, TSUIJIARAI, SHOWA-CHO NAKASE DECISION MADE: 05-SEP-12 YAMANASHI JA 409-3853 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: STRYKER SDC3 HD INFORMATION MANAGEMENT SYSTEM STRYKER ENDOSCOPY 510(k) NO: K121893(TRADITIONAL) ATTN: LIFEI LIU PHONE NO : 408 754 2315 5900 OPTICAL CT. SE DECISION MADE: 05-SEP-12 SAN JOSE CA 95138 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: LOQTEQ LARGE FRAGMENT SET LOQTEQ CORTICAL SCREW 4.5, SMALL HEAD, T25, SELF TAPPING LOQTEQ CORTICAL SCREW 4.5, T25, SELF AAP IMPLANTATE AG 510(k) NO: K113648(TRADITIONAL) ATTN: MARC SEEGERS PHONE NO : 493 075 019192 LORENZWEG 5 SE DECISION MADE: 06-SEP-12 BERLIN GM 12099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMPELLA 2.5 PLUS CATHETER ABIOMED, INC. 510(k) NO: K112892(SPECIAL) ATTN: CAROLYN PEKAR PHONE NO : 978 646 1639 22 CHERRY HILL DR. SE DECISION MADE: 06-SEP-12 DANVERS MA 01923 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FOCUS TOUCH CONCEPTION SYSTEM INTIMATE BRIDGE 2 CONCEPTION, INC 510(k) NO: K112200(TRADITIONAL) ATTN: NIKI C SPANIEL PHONE NO : 724 327 0230 3919 WILLIAM PENN HIGHWAY SUITE 20SE DECISION MADE: 06-SEP-12 MURRYSVILLE PA 15668 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PADLOCK CLIP-12 APONOS MEDICAL CORP. 510(k) NO: K120814(TRADITIONAL) ATTN: JOHN FEE PHONE NO : 603 702 0066 16 HILLSIDE RD. SE DECISION MADE: 06-SEP-12 KINGSTON NH 03848 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM CONFORMIS, INC. 510(k) NO: K121974(TRADITIONAL) ATTN: AMITA S SHAH PHONE NO : 781 345 9164 11 NORTH AVENUE SE DECISION MADE: 06-SEP-12 BURLINGTON MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM DIASORIN, INC. 510(k) NO: K122397(TRADITIONAL) ATTN: CAROL A DEPOUW PHONE NO : 651 351 5850 1951 NORTHWESTERN AVE. P.O. BOX 28SE DECISION MADE: 06-SEP-12 STILLWATER MN 55082 0285 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIES DATASCOPE CORP., CARDIAC ASSIST DI510(k) NO: K122628(SPECIAL) ATTN: CARLA S CERQUEIRA PHONE NO : 973 709 7340 15 LAW DR. SE DECISION MADE: 06-SEP-12 FAIRFIELD NJ 07004 0011 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE ADVANCED SURGICAL CONCEPTS 510(k) NO: K121309(SPECIAL) ATTN: JONATHAN KAHAN PHONE NO : 202 637 5794 355 THIRTEENTH STREET, NW COLUMBIASE DECISION MADE: 06-SEP-12 WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LOUTREX TOPICAL CREAM ACELLA PHARMACEUTICALS, LLC 510(k) NO: K120730(TRADITIONAL) ATTN: LARA NOAH PHONE NO : 803 831 7657 248 LATITUDE LANE SUITE 104 SE DECISION MADE: 06-SEP-12 LAKE WYLIE SC 29710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LENSSX LASER SYSTEM ALCON LENSX, INC. 510(k) NO: K120732(TRADITIONAL) ATTN: JUDY GORDON PHONE NO : 949 715 0609 733 BOLSANA DRIVE SE DECISION MADE: 06-SEP-12 LAGUNA BEACH CA 92651 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEPUY CTA REVERSE SHOULDER SYSTEM DEPUY FRANCE 510(k) NO: K122442(SPECIAL) ATTN: MEGAN BURNS PHONE NO : 574 372 7745 700 ORTHOPAEDIC DRIVE SE DECISION MADE: 06-SEP-12 WARSAW IN 46580 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAXLOCK EXTREME SYSTEM ORTHOHELIX SURGICAL DESIGNS, INC. 510(k) NO: K122005(SPECIAL) ATTN: DEREK LEWIS PHONE NO : 330 969 9562 1065 Medina Rd. SUITE 500 SE DECISION MADE: 06-SEP-12 Medina OH 44256 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SNOWDEN PENCER LAPAROSCOPIC ERGONOMIC REPOSABLE SCISSORS CAREFUSION 2200, INC. 510(k) NO: K113407(TRADITIONAL) ATTN: KATE FULLER PHONE NO : 847 473 7334 1500 WAUKEGAN ROAD SE DECISION MADE: 07-SEP-12 MCGAW PARK IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM TRANSONIC SYSTEMS, INC. 510(k) NO: K113821(TRADITIONAL) ATTN: NAVEEN THURAMALLA PHONE NO : 607 257 5300 34 Dutch Mill Rd SE DECISION MADE: 07-SEP-12 ITHACA NY 14850 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INFRARED THERMOMETER FAMIDOC TECHNOLOGY CO., LTD 510(k) NO: K113761(TRADITIONAL) ATTN: LEON CAO PHONE NO : 867 552 7864342 East 2/F,Zhixiang Building,71 BLOCSE DECISION MADE: 07-SEP-12 SHENZHEN CH 518101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PONTO BONE ANCHORED HEARING SYSTEM OTICON MEDICAL AB 510(k) NO: K121228(TRADITIONAL) ATTN: KAROLIN ISBERG JERNBY PHONE NO : 463 174 86153 EKONOMIVAGEN 2 SE DECISION MADE: 07-SEP-12 ASKIM SW SE-436 33 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: B&W DENTAL IMPLANT SYSTEM B&W SRL 510(k) NO: K120875(TRADITIONAL) ATTN: PRIYA BHUTANI PHONE NO : 54 11 48637878 CORRIENTES 3859 SE DECISION MADE: 07-SEP-12 BUENOS AIRES AR AR 510(k) STATEMENT DEVICE: MINIARC PRO SINGLE-INCISION SLING SYSTEM AMERICAN MEDICAL SYSTEMS 510(k) NO: K121641(TRADITIONAL) ATTN: RENEE MELLUM PHONE NO : 952 930 6458 10700 BREN ROAD WEST SE DECISION MADE: 07-SEP-12 MINNETONKA MN 55343 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITROS CHEMISTRY PRODUCTS DHDL SLIDES ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K120609(SPECIAL) ATTN: MARLENE A HANNA PHONE NO : 585 453 4041 100 INDIGO CREEK DR. SE DECISION MADE: 07-SEP-12 ROCHESTER NY 14646 5101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERACIA SHOFU DENTAL CORPORATION 510(k) NO: K121749(TRADITIONAL) ATTN: DAVID P MORAIS PHONE NO : 760 736 3277 1225 STONE DRIVE SE DECISION MADE: 07-SEP-12 SAN MARCOS CA 92078 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEMOCUE HBA1C 501 INFOPIA CO., LTD 510(k) NO: K121366(SPECIAL) ATTN: MARIA F GRIFFIN PHONE NO : 704 843 1675 55 NORTHERN BLVD. SUITE 200 SE DECISION MADE: 07-SEP-12 GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITREAVIEW VITAL IMAGES, INC. 510(k) NO: K122136(TRADITIONAL) ATTN: IAN NEMEROV PHONE NO : 952 487 9622 5850 Opus Pkwy Ste 300 SE DECISION MADE: 07-SEP-12 MINNETONKA MN 55343 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MASIMO SET USPO2 PULSE OXIMETRY CABLE MASIMO CORPORATION 510(k) NO: K121914(SPECIAL) ATTN: DAVID COLLETTE PHONE NO : 949 297 7000 40 PARKER SE DECISION MADE: 07-SEP-12 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMITH & NEPHEW, INC. SHOULDER SYSTEM INSTRUMENTS SMITH & NEPHEW, INC. 510(k) NO: K121714(TRADITIONAL) ATTN: BRADLEY HEIL PHONE NO : 901 399 6339 1450 BROOKS RD. SE DECISION MADE: 07-SEP-12 MEMPHIS TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARROW PICC POWERED BY ARROW VPS STYLET ARROW INTERNATIONAL(SUBSIDIARY OF 510(k) NO: K121941(SPECIAL) ATTN: ELIZABETH DUNCAN PHONE NO : 610 378 0131 2400 BERNVILLE RD. SE DECISION MADE: 07-SEP-12 READING PA 19605 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZYNO MEDICAL ADMINISTRATION SET ZYNO MEDICAL LLC 510(k) NO: K120685(ABBREVIATED) ATTN: CHAOYOUNG LEE PHONE NO : 508 650 2008 10 TECH CIRCLE SE DECISION MADE: 07-SEP-12 NATICK MA 01760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MINI PATCH WELL-LIFE HEALTHCARE LIMITED 510(k) NO: K121353(ABBREVIATED) ATTN: CHIN-CHIN HSIEH PHONE NO : 886 229 282112 1FL, NO.16, LANE 454 JUNGJENG RD. SE DECISION MADE: 07-SEP-12 YUNGHE CITY, TAIPEI COUNTY TW C510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE VASCULAR SOLUTIONS ZERUSA LTD. 510(k) NO: K122301(TRADITIONAL) ATTN: JENNIFER RUETHER PHONE NO : 763 656 4370 6464 SYCAMORE COURT SE DECISION MADE: 07-SEP-12 MINNEAPOLIS MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MR VESSELLQ XPRESS GE MEDICAL SYSTEMS SCS 510(k) NO: K122164(TRADITIONAL) ATTN: HELEN PENG PHONE NO : 262 548 5091 3000 NORTH GRANDVIEW W1140 SE DECISION MADE: 07-SEP-12 WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM CURVED LINEAR ARRAY 2-5 MHZ TRANSDUCER LINEAR ARRAY 5-11 MHZ TRANSDUCER PHASE ARRA BENQ MEDICAL TECHNOLOGY CORPATION 510(k) NO: K121983(TRADITIONAL) ATTN: BOB LEIKER PHONE NO : 925 556 1302 7263 CRONIN CIRCLE SE DECISION MADE: 07-SEP-12 DUBLIN CA 94568 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B BECTON, DICKINSON AND COMPANY 510(k) NO: K121797(TRADITIONAL) ATTN: GREGORY P PAYNE, RAC PHONE NO : 858 795 7890 10865 ROAD TO THE CURE, SUITE 200 SE DECISION MADE: 07-SEP-12 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BENCOX MIRABO CUP BENCOX MIRABO INSERT (STANDARD& ELEVATED TYES) BENCOX MIRABO CUP SCREW HOLE PLUG CORENTEC CO., LTD 510(k) NO: K120924(SPECIAL) ATTN: J.S. DANIEL PHONE NO : 820 743 933819 11TH CHUNGHO TOWER 748-1 BANPO 1 DSE DECISION MADE: 10-SEP-12 SEOCHO GU, SEOUL KS 137-040 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BAROSENSE ENDOGASTRIC TUBE AND INTRODUCER BOUGIE BAROSENSE, INC 510(k) NO: K120126(SPECIAL) ATTN: SHELIA STEVENS, PHD PHONE NO : 650 362 6000 250 CHESAPEAKE DRIVE SE DECISION MADE: 10-SEP-12 REDWOOD CITY CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNITY TOATAL KNEE SYSTEM CORIN U.S.A. 510(k) NO: K113060(TRADITIONAL) ATTN: LUCINDA GERBER PHONE NO : 813 977 4469 10500 UNIVERSITY CENTER DR., SUITESE DECISION MADE: 10-SEP-12 TAMPA FL 33612 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ESENSOR RESPIRATORY VIRAL PANEL CLINICAL MICRO SENSORS, INC. 510(k) NO: K113731(TRADITIONAL) ATTN: JOEL CENTENO PHONE NO : 760 448 4304 5964 LA PLACE COURT SE DECISION MADE: 10-SEP-12 CARLSBAD CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE SIAM SEMPERMED CORP. LTD. 510(k) NO: K122363(ABBREVIATED) ATTN: WILLIAM E HARRIS PHONE NO : 727 787 7250 13900 49TH STREET NORTH SE DECISION MADE: 10-SEP-12 CLEARWATER FL 33762 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXXXX MAQUET CARDIOVASCULAR, LLC 510(k) NO: K122612(TRADITIONAL) ATTN: MARYLOU INSINGA PHONE NO : 973 709 7442 45 BARBOUR POND DRIVE SE DECISION MADE: 10-SEP-12 WAYNE NJ 07470 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KDL DISPOSABLE INFUSION SET SHANGHAI KINDLY ENT. DEVELOPMENT G510(k) NO: K112204(TRADITIONAL) ATTN: DIANA HONG PHONE NO : 86 216 4264467 P.O. BOX 237-023 SE DECISION MADE: 10-SEP-12 SHANGHAI CH 200237 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ETS BLUE POWDER-FREE PATIENT NITRILE EXAMINATION GLOVES NORTHSTAR HEALTHCARE HOLDINGS 510(k) NO: K121947(TRADITIONAL) ATTN: WESLEY TOAVS PHONE NO : 441 278 3827 HAMILTON HOUSE, 10 QUEEN ST SE DECISION MADE: 10-SEP-12 HAMILTON, BERMUDA EI HM11 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: TAPERSET HIP SMALL STEMS CONSENSUS ORTHOPEDICS, INC. 510(k) NO: K121935(SPECIAL) ATTN: MATTHEW M HULL PHONE NO : 916 355 7156 1115 WINDFIELD WAY, SUITE 100 SE DECISION MADE: 10-SEP-12 EL DORADO HILLS CA 95762 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VISIONS PV .035 DITITAL IVUS CATHETER VOLCANO CORPORATION 510(k) NO: K121273(ABBREVIATED) ATTN: MARILYN POURAZAR PHONE NO : 858 720 4116 3661 Valley Centre Drive Suite 200SE DECISION MADE: 10-SEP-12 San Diego CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LANX SPINAL FIZATION SYSTEM LANX, INC. 510(k) NO: K121316(TRADITIONAL) ATTN: WILLIAM SANDUL PHONE NO : 303 443 7500 310 INTERLOCKEN PARKWAY SUITE 120 SE DECISION MADE: 10-SEP-12 BROOMFIELD CO 80021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR ANDON HEALTH CO., LTD 510(k) NO: K121372(SPECIAL) ATTN: LIU YI PHONE NO : 862 260 526161 No. 3 Jin Ping Street,Ya An Road, SE DECISION MADE: 10-SEP-12 TIANJIN CN 300190 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EARLYSENSE CENTRAL DISPLAY SYSTEM EARLYSENSE LTD. 510(k) NO: K121885(SPECIAL) ATTN: DALIA ARGAMAN PHONE NO : 972 375 22330X160 12 TZVI ST SE DECISION MADE: 10-SEP-12 RAMAT-GAN IS 52504 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DELICOT AMERICAN SURGICAL COMPANY, LLC 510(k) NO: K121822(SPECIAL) ATTN: ERIK PIASIO PHONE NO : 781 592 7200 82 SANDERSON AVENUE SE DECISION MADE: 10-SEP-12 Lynn MA 01902 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTEGRA CAMINO ICP MONITOR INTRGRA LIFESCIENCES CORPORATION 510(k) NO: K121573(TRADITIONAL) ATTN: ERIN DOYLE PHONE NO : 609 936 3634 311 ENTERPRISE DRIVE SE DECISION MADE: 10-SEP-12 PLAINSBORO NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MYOSURE XL TISSUE REMOVAL DEVICE (1 PACK) MYOSURE XL TISSUE REMOVAL DEVICE (3 PACK) HOLOGIC, INC. 510(k) NO: K122498(SPECIAL) ATTN: SARAH FAIRFIELD PHONE NO : 508 263 8857 250 CAMPUS DRIVE SE DECISION MADE: 10-SEP-12 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TESTOSTERONE TEST SYSTEM; CALIBRATOR; AND QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAYED) ABBOTT LABORATORIES 510(k) NO: K120009(TRADITIONAL) ATTN: JOHN RIZOS PHONE NO : 847 935 1813 100 ABBOTT PARK ROAD DEPT 9V6, AP5SE DECISION MADE: 11-SEP-12 ABBOTT PARK IL 60064 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EUROIMMUN ANTI-LKM-1 ELISA(LGG) EUROIMMUN US 510(k) NO: K112223(TRADITIONAL) ATTN: KATHRYN KOHL PHONE NO : 973 656 1000 1100 THE AMERICAN ROAD SE DECISION MADE: 11-SEP-12 MORRIS PLAINS NJ 07950 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EUROIMMUN ANTI-SLA/LP ELISA(LGG) EUROIMMUN US 510(k) NO: K112221(TRADITIONAL) ATTN: KATHRYN KOHL PHONE NO : 973 656 1000 1100 THE AMERICAN ROAD SE DECISION MADE: 11-SEP-12 MORRIS PLAINS NJ 07950 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE BLACK NITRILE EXAMINATION GLOVES TG MEDICAL SDN BHD 510(k) NO: K113393(TRADITIONAL) ATTN: NOOR A SAIDIN PHONE NO : 033 392 7880 LOT 5091, JALAN TERATAI, BT 5, OFFSE DECISION MADE: 11-SEP-12 KLANG, SELANGOR MY 41050 510(k) STATEMENT DEVICE: ABUTMENT FOR COMPETITIVE IMPLANT NOBEL ACTIVE CONNECTION BIOMET 3I 510(k) NO: K120776(SPECIAL) ATTN: TAMARA WEST PHONE NO : 561 776 6831 4555 RIVERSIDE DR. SE DECISION MADE: 11-SEP-12 Palm Bch Gdns FL 33410 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWER-FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR SHEN WEI (USA), INC. 510(k) NO: K121528(TRADITIONAL) ATTN: ALBERT LI PHONE NO : 540 429 8692 33278 CENTRAL AVE., SUITE 102 SE DECISION MADE: 11-SEP-12 UNION CITY CA 94587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT BECKMAN COULTER, INC. 510(k) NO: K121492(SPECIAL) ATTN: ANNETTE HELLIE PHONE NO : 714 961 4517 250 SOUTH KRAEMER BLVD A2.SW.09 SE DECISION MADE: 11-SEP-12 BREA CA 92822 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROTH NET RETRIEVER UNITED STATES ENDOSCOPY GROUP, INC510(k) NO: K122462(SPECIAL) ATTN: CARROLL MARTIN PHONE NO : 440 639 4494 5976 HEISELY RD. SE DECISION MADE: 11-SEP-12 MENTOR OH 44060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOMATOM DEFINITION SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K122471(SPECIAL) ATTN: KIMBERLY MANGUN PHONE NO : 610 448 4912 51 VALLEY STREAM PARKWAY SE DECISION MADE: 11-SEP-12 MALVERN PA 19355 1406 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (MODIFICATION) PROSURG, INC. 510(k) NO: K120766(TRADITIONAL) ATTN: A. DESAI PHONE NO : 408 945 4044 2195 TRADE ZONE BLVD. SE DECISION MADE: 11-SEP-12 SAN JOSE CA 95131 510(k) STATEMENT DEVICE: C2-9-D ULTRASOUND TRANSDUCER GE HEALTHCARE 510(k) NO: K122515(SPECIAL) ATTN: BRYAN BEHN PHONE NO : 414 721 4214 9900 INNOVATION DRIVE SE DECISION MADE: 11-SEP-12 WAUWATOSA WI 53226 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RANGE SPINAL SYSTEM K2M, INC. 510(k) NO: K121630(TRADITIONAL) ATTN: NANCY GIEZEN PHONE NO : 703 777 3155 751 MILLER DR., S.E., SUITE F1 SE DECISION MADE: 11-SEP-12 Leesburg VA 20175 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUINTEX CERVICAL PLATING SYSTEM AESCULAP IMPLANT SYSTEMS, LLC 510(k) NO: K121801(TRADITIONAL) ATTN: LISA BOYLE PHONE NO : 610 797 9300 3773 CORPORATE PARKWAY SE DECISION MADE: 11-SEP-12 CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTEGRA JARIT VIDEO ASSISTED THORACIC SURGERY INSTRUMENTS INTEGRA LIFESCIENCES CORPORATION 510(k) NO: K120012(TRADITIONAL) ATTN: STEPHANIE SHEESLEY PHONE NO : 717 840 2774 589 DAVIES DRIVE SE DECISION MADE: 11-SEP-12 YORK PA 17402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUVASIVE PRECEPT SPINAL SYSTEM NUVASIVE, INC. 510(k) NO: K122352(TRADITIONAL) ATTN: ELIAS KETCHUM PHONE NO : 858 320 4588 7475 LUSK BLVD SE DECISION MADE: 11-SEP-12 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VOLUSON P6, VOLUSON P8 GE HEALTHCARE 510(k) NO: K122387(TRADITIONAL) ATTN: BRYAN BEHN PHONE NO : 414 721 4214 9900 INNOVATION DRIVE SE DECISION MADE: 11-SEP-12 WAUWATOSA WI 53226 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROTECTOR, INJECTOR, CONNECTOR BD MEDICAL-MEDICAL SURGICAL SYSTEM510(k) NO: K120384(TRADITIONAL) ATTN: JOHN ROBERTS PHONE NO : 201 847 5473 1 BECTON DRIVE SE DECISION MADE: 12-SEP-12 FRANKLIN LAKES NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NON-STERILE, POWER FREE YELLOW LATEX EXAMINATION GLOVES SGMP CO., LTD. 510(k) NO: K112693(TRADITIONAL) ATTN: JANNA P TUCKER PHONE NO : 775 342 2612 198 AVENUE DE LA D'EMERALD SE DECISION MADE: 12-SEP-12 SPARKS NV 89434 510(k) STATEMENT DEVICE: LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC LAVA ULTIMATE CAD/CAM RESTORATIVE FOR E4D LAVA ULTIMATE IMPLANT CROWN RESTOR 3M COMPANY 510(k) NO: K122569(TRADITIONAL) ATTN: GINGER CANTOR PHONE NO : 651 733 1317 2510 CONWAY AVENUE SE DECISION MADE: 12-SEP-12 ST. PAUL MN 55144 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CS ORTHODONTIC IMAGING SOFTWARE CS OMS IMAGING SOFTWARE CARESTREAM DENTAL LLC 510(k) NO: K122427(SPECIAL) ATTN: DANIEL HOEFER PHONE NO : 770 226 3287 1765 THE EXCHANGE SE DECISION MADE: 12-SEP-12 ATLANTA GA 30339 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRYKER VIDEO URETEROSCOPE STRYKER ENDOSCOPY 510(k) NO: K121112(TRADITIONAL) ATTN: KEVIN POTGIETER, RAC PHONE NO : 408 754 2000 5900 OPTICAL CT. SE DECISION MADE: 12-SEP-12 SAN JOSE CA 95138 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALCO-SCREEN 02 CHEMATICS, INC. 510(k) NO: K121256(TRADITIONAL) ATTN: CARL REYNOLDS PHONE NO : 513 265 6257 P.O. BOX 293 HIGHWAY 13 SOUTH SE DECISION MADE: 12-SEP-12 NORTH WEBSTER IN 46555 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AYCAN MOBILE AYCAN DIGITALSYSTEME GMBH 510(k) NO: K122260(TRADITIONAL) ATTN: MATTHIAS BROENNER PHONE NO : 49 931 2704090 INNERE AUMUEHL STRASSE 5 SE DECISION MADE: 12-SEP-12 WUERZBURG GM 97076 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITAL COUGH LUNG ASSIST, INC. 510(k) NO: K120277(TRADITIONAL) ATTN: LEWIS WARD PHONE NO : 303 516 1024 4655 KIRKWOOD COURT SE DECISION MADE: 12-SEP-12 BOULDER CO 80301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LABONACHECK ALC CERAGEM INTERNATIONAL, INC. 510(k) NO: K111128(TRADITIONAL) ATTN: RAYMOND CHUNG PHONE NO : 213 480 7168 3699 WILSHIRE BLVD.,SUITE 930 SE DECISION MADE: 13-SEP-12 LOS ANGELES CA 90010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMMUNOCAP ALLERGEN COMPONENTS BUNDLE PHADIA US INC. 510(k) NO: K113841(TRADITIONAL) ATTN: MARTIN MANN PHONE NO : 269 492 1957 4169 COMMERCIAL AVE. SE DECISION MADE: 13-SEP-12 PORTAGE MI 49002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERRAD(R) 100NX STERILIZER DUO CYCLE ADVANCED STERILIZATION PRODUCTS 510(k) NO: K111377(TRADITIONAL) ATTN: NANCY CHU PHONE NO : 949 453 6435 33 TECHNOLOGY DR. SE DECISION MADE: 13-SEP-12 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVE LIFESTYLE SAFTY PRODUCTS (HUI ZHOU510(k) NO: K112741(ABBREVIATED) ATTN: RHONDA T ALEXANDER PHONE NO : 757 224 0177 MEDICAL DEVICE & DRUG DEVISION 144SE DECISION MADE: 13-SEP-12 HAMPTON VA 23666 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIAMO SSA-640A V4.0 TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K122491(TRADITIONAL) ATTN: CHARLEMAGNE CHUA PHONE NO : 714 730 5000 2441 MICHELLE DRIVE SE DECISION MADE: 13-SEP-12 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: TRIA LASER HAIR REMOVAL SYSTEM TRIA BEAUTY, INC. 510(k) NO: K120737(TRADITIONAL) ATTN: JONATHAN KAHAN PHONE NO : 202 638 5794 555 13TH STREET, NW COLUMBIA SQUARSE DECISION MADE: 13-SEP-12 WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VAN GOGH ANTERIOR CERVICAL PLATE SYSTEM ACCEL SPINE 510(k) NO: K121078(TRADITIONAL) ATTN: DANIEL CHON PHONE NO : 800 713 9489 14850 Quorum Dr Ste 220 SE DECISION MADE: 13-SEP-12 Dallas TX 75254 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JAZZ SYSTEM IMPLANET S.A. 510(k) NO: K121541(TRADITIONAL) ATTN: JANICE M HOGAN PHONE NO : 267 675 4611 1835 MARKET ST. 29TH FLOOR SE DECISION MADE: 13-SEP-12 PHILADELPHIA PA 19103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH PERIPHERAL ROTALINK PLUS BOSTON SCIENTIFIC CORP. 510(k) NO: K121774(TRADITIONAL) ATTN: BETH TOROK PHONE NO : 763 494 1273 ONE SCIMED PLACE SE DECISION MADE: 13-SEP-12 MAPLE GROVE MN 55311 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STREPTOCOCCUS APP. SEROLOGICAL REAGENTS MERIDIAN BIOSCIENCE, INC. 510(k) NO: K122019(TRADITIONAL) ATTN: MICHELLE L SMITH PHONE NO : 513 271 3700 3471 RIVER HILLS DR. SE DECISION MADE: 13-SEP-12 CINCINNATI OH 45244 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PATIENT POSITIONING SYSTEM FORTE AUTOMATION SYSTEMS, INC. 510(k) NO: K122413(TRADITIONAL) ATTN: PHIL REECE PHONE NO : 815 633 2300 8155 Burden Rd SE DECISION MADE: 13-SEP-12 Machesney Park IL 61115 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2 OPTIM LLC 510(k) NO: K122593(SPECIAL) ATTN: JEFF BARRETT PHONE NO : 508 347 5100 64 TECHNOLOGY PARK RD SE DECISION MADE: 13-SEP-12 STURBRIDGE MA 01566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: G-DERM POWDER-FREE SYNTHETIC SURGICAL GLOVE HUTCHINSON SANTE S.N.C. 510(k) NO: K121335(TRADITIONAL) ATTN: RAFFI KRIKORIAN PHONE NO : 330 344 738700 RUE MARRET PATUREL SE DECISION MADE: 13-SEP-12 LIANCOURT FR F-60140 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GSI VIEWER WITH VUE OPTION GE MEDICAL SYSTEMS SCS 510(k) NO: K121827(TRADITIONAL) ATTN: HELEN PENG PHONE NO : 262 548 5091 3000 NORTH GRANDVIEW W1140 SE DECISION MADE: 13-SEP-12 WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VELASHAPE SYNERON MEDICAL LTD. 510(k) NO: K122579(SPECIAL) ATTN: SAM WADE PHONE NO : 972 54 3303402 INDUSTRIAL ZONE TAVOR BLDG P.O.B 5SE DECISION MADE: 13-SEP-12 YOKNEAM, ILLIT IS 20692 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AIM INNEROPTIC TECHNOLOGY, INC 510(k) NO: K121479(TRADITIONAL) ATTN: CAROLINE GREEN PHONE NO : 919 732 2090 106-A N CHURTON ST SE DECISION MADE: 13-SEP-12 HILLSBOROUGH NC 27278 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DX-D FULL LEG FULL SPINE AFGA HEALTHCARE N.V. 510(k) NO: K122119(TRADITIONAL) ATTN: DAVID LEDWIG PHONE NO : 828 862 8555 PO BOX 1927 SE DECISION MADE: 13-SEP-12 BREVARD NC 28712 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIRTUOST O.N. DIAGNOSTICS 510(k) NO: K113725(TRADITIONAL) ATTN: DAVID KOPPERDAHL PHONE NO : 510 204 0688 2150 SHATTUCK AVE. SUITE 610 SE DECISION MADE: 13-SEP-12 BERKELEY CA 94704 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AFFINITY PIXIE OXYGENATION SYSTEM WITH CARMEDA BIOACTIVE SURFACE OR BALANCE BIOSURFACE MEDTRONIC INC. 510(k) NO: K100645(TRADITIONAL) ATTN: JESSICA SIXBERRY PHONE NO : 763 514 9849 7611 NORTHLAND DRIVE SE DECISION MADE: 14-SEP-12 BROOKLYN PARK MN 55428 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORRECTINJECT SAFETY SYSTEM, CATHETER CONNECTOR, FILTER, INFUSION ADAPTOR, SYRINGE KIT SMITHS MEDICAL ASD, INC. 510(k) NO: K110053(TRADITIONAL) ATTN: CINDY ENGELHARDT PHONE NO : 603 352 3812 10 BOWMAN DR. SE DECISION MADE: 14-SEP-12 KEENE NH 03431 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORIN METAFIX HIP STEM CORIN U.S.A. 510(k) NO: K121439(TRADITIONAL) ATTN: LUCINDA GERBER PHONE NO : 813 977 4469 10500 UNIVERSITY CENTER DR., SUITESE DECISION MADE: 14-SEP-12 TAMPA FL 33612 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMAGER II ANGIOGRAPHIC CATHETER BOSTON SCIENTIFIC CORP. 510(k) NO: K121694(TRADITIONAL) ATTN: HOLLY RAMIREZ PHONE NO : 763 484 2113 ONE SCIMED PLACE SE DECISION MADE: 14-SEP-12 MAPLE GROVE MN 55311 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OXFORD ANKLE FUSION NAIL(AFN) SYSTEM ORTHO SOLUTIONS LIMITED 510(k) NO: K121575(TRADITIONAL) ATTN: AL LIPPINCOTT PHONE NO : 952 492 5858 3150 EAST 200TH STREET SE DECISION MADE: 14-SEP-12 PRIOR LAKE MN 55372 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LULLABY TM WARMER WIPRO GE HEALTHCARE PRIVATE, LTD. 510(k) NO: K121625(TRADITIONAL) ATTN: AGATA ANTHONY PHONE NO : 410 456 0329 8880 GOMAN ROAD SE DECISION MADE: 14-SEP-12 LAUREL MD 20723 5800 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERRAD (R) CYCLESURE (R) 24 BIOLOGICAL INDICATOR ADVANCED STERILIZATION PRODUCTS 510(k) NO: K111375(TRADITIONAL) ATTN: NANCY CHU PHONE NO : 949 453 6435 33 TECHNOLOGY DR. SE DECISION MADE: 14-SEP-12 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUPRA SCAN DELIVERY SYSTEM QUANTEL MEDICAL 510(k) NO: K120825(TRADITIONAL) ATTN: MAUREEN O'CONNELL PHONE NO : 978 207 1245 5 TIMBER LANE SE DECISION MADE: 14-SEP-12 NORTH READING MA 01864 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PEEK CUSTOMIZED CRAIAL IMPLANT KIT STRYKER 510(k) NO: K121153(TRADITIONAL) ATTN: MANISH PATEL PHONE NO : 269 389 4271 750 TRADE CENTER WAY STE 200 SE DECISION MADE: 14-SEP-12 PORTAGE MI 49002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZMR HIP SYSTEM KWZ-PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER ZIMMER, INC. 510(k) NO: K113296(TRADITIONAL) ATTN: DANIEL J WILLIMAN PHONE NO : 574 371 8065 P.O. BOX 708 SE DECISION MADE: 14-SEP-12 WARSAW IN 46581 0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGNITY POWER INJECTABLE TITANIUM PORT MEDICAL COMPONENTS INC 510(k) NO: K120281(TRADITIONAL) ATTN: ROSANNA SEVERINI PHONE NO : 215 256 4201 1499 DELP DRIVE SE DECISION MADE: 17-SEP-12 HARLEYSVILLE PA 19438 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODEL FAMILY OF AEROLASE ND:YAG LASERS: FRIENDLYLIGHT ND: YAG LASERS, FRIENDLYLIGHT NEO, LIGHTPOD ND: YAG LASERS, LIGHTP AEROLASE MEDICAL LASERS LLC 510(k) NO: K120235(TRADITIONAL) ATTN: JENNIFER A HENDERSON PHONE NO : 202 637 5783 555 THIRTEENTH STREET SE DECISION MADE: 17-SEP-12 WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORIGINS LIPOHARVESTING SYSTEM SOUND SURGICAL TECHNOLOGIES LLC. 510(k) NO: K120328(TRADITIONAL) ATTN: STEPHEN C SMITH PHONE NO : 720 240 2970 357 McCaslin Blvd Ste 100 SE DECISION MADE: 17-SEP-12 LOUISVILLE CO 80027 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KMC KYPHOPLASTY SYSTEM SHANGHAI KINETIC MEDICAL CO., LTD 510(k) NO: K113742(TRADITIONAL) ATTN: GREGORY MATHISON PHONE NO : 218 387 1559 3924CASCADE BEACH ROAD SE DECISION MADE: 17-SEP-12 LUTSEN MN 55612 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOFIBER SYTURE TORNIER, INC. 510(k) NO: K122487(TRADITIONAL) ATTN: LAEL J PICKETT PHONE NO : 612 219 7350 10801 NESBITT AVENUE SE DECISION MADE: 17-SEP-12 BLOOMINGTON MN 55437 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMERIWATER ALARM PANEL - BASE MODEL AND REMOTE, BASE MODEL & REMOTE WITH CONDUCTIVITY, BASE MODEL & REMOTE WITH RESISTIV AMERIWATER 510(k) NO: K121022(TRADITIONAL) ATTN: BRIAN BOWMAN PHONE NO : 937 461 8833 1303 STANLEY AVE. SE DECISION MADE: 17-SEP-12 DAYTON OH 45404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TIGRAN PERIBRUSH TIGRAN TECHNOLOGIES AB 510(k) NO: K121114(TRADITIONAL) ATTN: ULF LUNDGREN PHONE NO : 464 065 01666 Medeon Science Park SE DECISION MADE: 17-SEP-12 Malmo SE 205 12 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUREFIRE HIGH FLOW ANGIOGRAPHIC CATHETER, ACCESS SUREFIRE MEDICAL, INC 510(k) NO: K122506(TRADITIONAL) ATTN: MARIO ARBESU PHONE NO : 305 378 2651 12415 SW 136 AVENUE UNIT 3 SE DECISION MADE: 17-SEP-12 MIAMI FL 33186 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBES KATALYST SURGICAL, LLC 510(k) NO: K121187(TRADITIONAL) ATTN: MICHELLE MCDONOUGH PHONE NO : 202 552 5800 1331 H ST NW, 12TH FL SE DECISION MADE: 17-SEP-12 WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BICERA (TM) RESORBABLE BONE SUBSTITUTE WILTROM CORPORATION LIMITED 510(k) NO: K110949(TRADITIONAL) ATTN: YUNG-CHIH WU PHONE NO : 886 358 28999 NO. 221, SEC 1, CHUNG HSING RD SE DECISION MADE: 18-SEP-12 CHUTUNG TOWNSHIP, HSINCHU TW 31510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SCKOONCUP SCKOON INC. 510(k) NO: K120107(TRADITIONAL) ATTN: MOHAMED ELGAYAR PHONE NO : 212 228 6903 2301 COLLINS AVE #310 SE DECISION MADE: 18-SEP-12 MIAMI BEACH FL 33139 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ISIGHT C & E GP SPECIALISTS, INC. 510(k) NO: K121519(TRADITIONAL) ATTN: MARTIN DALSING PHONE NO : 970 243 5490 2214 SANFORD DR SE DECISION MADE: 18-SEP-12 GRAND JUNCTION CO 81505 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD VERITOR(TM) SYSTEM FOR THE RAPID DETECTION OF RSV BECTON, DICKINSON AND COMPANY 510(k) NO: K121633(TRADITIONAL) ATTN: GREGORY P PAYNE PHONE NO : 858 795 7890 10865 ROAD TO THE CURE, SUITE 200 SE DECISION MADE: 18-SEP-12 SAN DIEGO CA 92064 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLYDESDALE SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K122591(SPECIAL) ATTN: BECKY RONNER PHONE NO : 800 876 3133 1800 PYRAMID PLACE SE DECISION MADE: 18-SEP-12 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHETER BOSTON SCIENTIFIC CORP. 510(k) NO: K121614(TRADITIONAL) ATTN: LAUREN ANDERSON PHONE NO : 508 683 4707 100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 18-SEP-12 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WALK ON WHEELS HS-3500 ELECTRIC AISLE WHEELCHAIR WALK ON WHEELS AUSTRALIA PTY LTD 510(k) NO: K120405(TRADITIONAL) ATTN: SHEILA RAMERMAN PHONE NO : 541 683 3017 927 THRONE DR. SE DECISION MADE: 19-SEP-12 EUGENE OR 97402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTEM NIHON KOHDEN CORP. 510(k) NO: K120397(TRADITIONAL) ATTN: STEVE GEERDES PHONE NO : 949 580 1555 90 ICON STREET SE DECISION MADE: 19-SEP-12 FOOTHILL RANCH CA 92610 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SLEEP PROFILER ADVANCED BRAIN MONITORING, INC. 510(k) NO: K120450(TRADITIONAL) ATTN: ADRIENNE LENZ PHONE NO : 262 290 0023 W324 S3649 COUNTY RD E SE DECISION MADE: 19-SEP-12 DOUSMAN WI 53118 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM BIOMET MICROFIXATION 510(k) NO: K121302(SPECIAL) ATTN: SHERYL MALMBERG PHONE NO : 904 741 9465 1520 TRADEPORT DR. SE DECISION MADE: 19-SEP-12 JACKSONVILLE FL 32218 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHOCAD SOFTWARE OPTION ESAOTE, S.P.A. 510(k) NO: K120288(TRADITIONAL) ATTN: ALLISON SCOTT, RAC PHONE NO : 317 569 9500 9001 WESLEYAN ROAD SUITE 200 SE DECISION MADE: 19-SEP-12 INDIANAPOLIS IN 46268 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MINDCHILD MERIDIAN FETAL HEART RATE MONITOR MINDCHILD MEDICAL 510(k) NO: K120018(TRADITIONAL) ATTN: LEO BASTA PHONE NO : 617 834 9866 755 WESTMINSTER STREET UNIT 120 SE DECISION MADE: 19-SEP-12 PROVIDENCE RI 02903 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MERIT HYDROPHILIC GUIDE WIRE MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K120644(TRADITIONAL) ATTN: MARK MULLANEY PHONE NO : 353 917 03761 PARKMORE BUSINESS PARK WEST SE DECISION MADE: 19-SEP-12 GALWAY EI EI 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED) TANGSHAN ZHONGHONG PULIN PLASTIC C510(k) NO: K120968(TRADITIONAL) ATTN: CHU XIAOAN PHONE NO : 861 082 387441 RM 1606 BLDG 1 JIANXIANG YUAN NO.2SE DECISION MADE: 19-SEP-12 BEIJING CH CH 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: METS MODULAR DISTAL FEMUR STANMORE IMPLANTS WORLDWIDE LTD 510(k) NO: K121029(TRADITIONAL) ATTN: NANCY C MACDONALD PHONE NO : 781 329 2993 690 CANTON STREET SUITE 302 SE DECISION MADE: 19-SEP-12 WESTWOOD MA 02090 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: METS MODULAR TOTAL FEMUR STANMORE IMPLANTS WORLDWIDE LTD. 510(k) NO: K121055(TRADITIONAL) ATTN: NANCY C MACDONALD PHONE NO : 781 329 2993 690 CANTON STREET SUITE 302 SE DECISION MADE: 19-SEP-12 WESTWOOD MA 02090 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MASIMO SET AND MASIMO RAINBOW SET PULSE OXIMETERS AND SENSORS MASIMO CORPORATION 510(k) NO: K120657(TRADITIONAL) ATTN: PATRICIA MILBANK PHONE NO : 949 297 7000 40 PARKER SE DECISION MADE: 19-SEP-12 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PENUMBRA EMBOLECTOMY ASPIRATION SYSTEM PENUMBRA, INC. 510(k) NO: K121917(TRADITIONAL) ATTN: MICHAELA MAHL PHONE NO : 510 748 3288 1351 Harbor Bay Parkway SE DECISION MADE: 19-SEP-12 Alameda CA 94502 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITASCAN LT SCANMASTER VITACON MEDICAL INC. 510(k) NO: K121689(TRADITIONAL) ATTN: RON EVANS PHONE NO : 604 291 7747 5355 Parkwood Place SE DECISION MADE: 19-SEP-12 Richmond CA V6V 2N1 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDURAMESH LUCERO MEDICAL, LLC 510(k) NO: K122622(SPECIAL) ATTN: JENNIFER PALINCHIK PHONE NO : 440 933 8850 33490 PIN OAK PARKWAY SE DECISION MADE: 19-SEP-12 AVON LAKE OH 44012 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST NANOSPHERE, INC 510(k) NO: K122514(TRADITIONAL) ATTN: MARK DEL VECCHIO PHONE NO : 847 400 9000 4088 COMMERCIAL AVENUE SE DECISION MADE: 19-SEP-12 NORTHBROOK IL 60062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MYOSURE XL ROD LENS HYSTEROSCOPE, MYOSURE XL OUTLFOW CHANNEL HOLOGIC, INC. 510(k) NO: K122563(SPECIAL) ATTN: SARAH FAIRFIELD PHONE NO : 508 263 8857 250 CAMPUS DRIVE SE DECISION MADE: 19-SEP-12 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K121224(SPECIAL) ATTN: LINDA KO PHONE NO : 886 266 258188 3F,5F, No.127, Wugong 2nd Rd. WuguSE DECISION MADE: 19-SEP-12 New Taipei City TW 24888 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CERASORB DENTAL,CERADORB M DENTAL, CERASORB PERIO RIEMSER ARZEIMITTEL AG 510(k) NO: K113282(SPECIAL) ATTN: JAMES M CLINTON PHONE NO : 919 247 0479 5105 FAIROAKS RD SE DECISION MADE: 20-SEP-12 DURHAM NC 27712 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORS INOVA DIAGNOSTICS, INC. 510(k) NO: K113863(TRADITIONAL) ATTN: GABRIELLA LAKOS PHONE NO : 858 586 9900 9900 OLD GROVE RD. SE DECISION MADE: 20-SEP-12 SAN DIEGO CA 92131 1638 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION) INOVISE MEDICAL, INC. 510(k) NO: K120462(TRADITIONAL) ATTN: EARL ANDERSON PHONE NO : 503 431 3800 8770 SW NIMBUS AVE. SUITE D SE DECISION MADE: 20-SEP-12 Beaverton OR 97008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEOMED ORAL/ENTERAL SYRINGE NEOMED, INC. 510(k) NO: K122373(SPECIAL) ATTN: MELINDA HARRISON PHONE NO : 770 516 2225 100 Londonderry Ct Suite 112 SE DECISION MADE: 20-SEP-12 Woodstock GA 30188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRASAFE PASSIVE NEEDLE GUARD SAFETY SYRINGES, INC. 510(k) NO: K122558(SPECIAL) ATTN: SUZANNE RICHARDSON PHONE NO : 760 918 9908 2875 Loker Ave E SE DECISION MADE: 20-SEP-12 CARLSBAD CA 92010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIPER AND EXPEDIUM NAVIGATED INSTRUMENTS MEDOS INTERNATIONAL SARL 510(k) NO: K120867(TRADITIONAL) ATTN: LAURA BLEYENDAAL PHONE NO : 508 828 3267 325 PARAMOUNT DRIVE SE DECISION MADE: 20-SEP-12 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: METS MODULAR PROXIMAL FEMUR STANMORE IMPLANTS WORLDWIDE LTD. 510(k) NO: K121056(TRADITIONAL) ATTN: NANCY C MACDONALD PHONE NO : 781 329 2993 690 CANTON STREET SUITE 302 SE DECISION MADE: 20-SEP-12 WESTWOOD MA 02090 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERISPINE LC CAGE SAFE ORTHOPAEDICS 510(k) NO: K122021(ABBREVIATED) ATTN: P. DUMOUCHEL PHONE NO : 330 134 215000 PARC DES BELLEVUES- ALLEE R LUXEMBSE DECISION MADE: 20-SEP-12 ERAGNY SUR OISE FR 95610 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2 RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K121724(TRADITIONAL) ATTN: RON HASELHORST PHONE NO : 847 913 1113 353 CORPORATE WOODS PKWY. SE DECISION MADE: 20-SEP-12 VERNON HILLS IL 60061 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 1.5T SIGNA HDXT 3.0 SIGNA HDXT SIGNA VIBRABT GE MEDICAL SYSTEMS, LLC 510(k) NO: K121676(TRADITIONAL) ATTN: SHASHIDHAR CS PHONE NO : 262 521 6848 3200 N. GRANDVIEW BLVD. SE DECISION MADE: 20-SEP-12 WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP) ORTHOFIX SRL 510(k) NO: K122541(SPECIAL) ATTN: CANDACE F CEDERMAN PHONE NO : 503 201 2485 22423 SKYVIEW DRIVE SE DECISION MADE: 20-SEP-12 WEST LINN OR 97068 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: E-CUBE 7 ALPINION MEDICAL SYSTEMS CO., LTD 510(k) NO: K121729(TRADITIONAL) ATTN: YUCHI CHU PHONE NO : 425 949 4907 SUITE 226, 10604 NE 38TH PLACE SE DECISION MADE: 20-SEP-12 KIRKLAND WA 98033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLUE, LATEX POWDER FREE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH PROTEIN LABLING CLAIM (50UG/DM NORTHSTAR HEALTHCARE HOLDINGS 510(k) NO: K121926(TRADITIONAL) ATTN: WESLEY TOAVS PHONE NO : 441 278 3827 HAMILTON HOUSE, 10 QUEEN ST SE DECISION MADE: 20-SEP-12 HAMILTON, BERMUDA EI HM11 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CHAMP CHAMP TRANSIT CONVAID PRODUCTS, INC. 510(k) NO: K120501(TRADITIONAL) ATTN: MERVYN WATKINS PHONE NO : 310 618 0111 2830 CALIFORNIA ST. SE DECISION MADE: 20-SEP-12 TORRANCE CA 90503 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDEFLUSH NORMAL SALINE I.V. FLUSH SYRINGE-STERILE FIELD READY MEDEFIL, INC. 510(k) NO: K121262(SPECIAL) ATTN: PRADEEP AGGARWAL PHONE NO : 630 682 4600 250 WINDY POINT DR. SE DECISION MADE: 20-SEP-12 GLENDALE HEIGHTS IL 60139 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHOICE SPINE FIXATION SYSTEM CHOICE SPINE, LP 510(k) NO: K121850(TRADITIONAL) ATTN: KIM FINCH PHONE NO : 865 246 3969 400 Erin Dr SE DECISION MADE: 20-SEP-12 KNOXVILLE TN 37919 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3 RANDOX LABORATORIES, LTD. 510(k) NO: K113720(TRADITIONAL) ATTN: PAULINE ARMSTRONG PHONE NO : 440 289 4422413 55 DIAMOND RD. SE DECISION MADE: 20-SEP-12 CRUMLIN, COUNTY ANTRIM UK BT29 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VESTIBULAR ANALYSIS APPARATUS CAPACITY SPORTS, LLC 510(k) NO: K121590(TRADITIONAL) ATTN: PAMELA M BUCKMAN PHONE NO : 925 980 7007 2800 PLEASANT HILL SUITE 175 SE DECISION MADE: 20-SEP-12 PLEASANT HILL CA 94523 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEXTGEN ALTIUS OCT SYSTEM BIOMET SPINE (AKA EBI, LLC) 510(k) NO: K122378(SPECIAL) ATTN: VIVIAN KELLY PHONE NO : 973 299 9300 100 INTERPACE PARKWAY SE DECISION MADE: 20-SEP-12 PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CG+ ARROW PICC POWERED BY ARROW VPS STYLET ARROW INTERNATIONAL(SUBSIDIARY OF 510(k) NO: K122545(SPECIAL) ATTN: ELIZABETH DUNCAN PHONE NO : 610 378 0131 2400 BERNVILLE RD. SE DECISION MADE: 20-SEP-12 READING PA 19605 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECHOSOFT(TM) ECHOMETRIX LLC 510(k) NO: K111142(TRADITIONAL) ATTN: LARRY A KROGER PHONE NO : 262 549 6646 2210 WOODHILL WAY SE DECISION MADE: 21-SEP-12 WAUKESHA WI 53189 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HUMID-VENT HEPA TELEFLEX MEDICAL 510(k) NO: K112958(TRADITIONAL) ATTN: LIZ PAUL PHONE NO : 919 433 8076 2917 WECK DR. SE DECISION MADE: 21-SEP-12 RESEARCH TRIANGLE PARK NC 27709 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTIAL PRO STENT POSITIONING SYSTEM MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K122089(SPECIAL) ATTN: DAVID THOMAS PHONE NO : 801 316 4956 1600 WEST MERIT PKWY. SE DECISION MADE: 21-SEP-12 SOUTH JORDAN UT 84095 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NIMBUS ELECTROSURGICAL RADIOFREQUENCY MULTITINED EXPANDABLE ELECTRODE BIOMERICS 510(k) NO: K121773(TRADITIONAL) ATTN: EMILY MADSEN PHONE NO : 801 355 2705 2700 S 900 W SE DECISION MADE: 21-SEP-12 SALT LAKE CITY UT 84119 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ADIPREP ADIPOSE TRANSFER SYSTEM HARVEST TECHNOLOGIES, CORP. 510(k) NO: K121005(TRADITIONAL) ATTN: GABRIEL J MURACA, JR. PHONE NO : 508 732 7500 40 GRISSOM RD, SUITE 100 SE DECISION MADE: 21-SEP-12 PLYMOUTH MA 02360 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT SPEEDLOCK HIP DRILL SPEEDLOCK HIP GUIDE CROWN TIP SPEEDLOCK HIP PATHFINDER ARTHROCARE CORPORATION 510(k) NO: K120943(TRADITIONAL) ATTN: CHERYL FREDRICK PHONE NO : 521 358 5751 7000 WEST WILLIAM CANNON DRIVE BUISE DECISION MADE: 21-SEP-12 AUSTIN TX 78735 0000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VOLUSON E6/E8/E8EXPERT/E10 GE HEALTHCARE 510(k) NO: K122327(TRADITIONAL) ATTN: BRYAN BEHN PHONE NO : 414 721 4214 9900 W INNOVATION DRIVE SE DECISION MADE: 21-SEP-12 WAUWATOSA WI 53226 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRISM ACQUIRE PRISM PROCESS PRISM VIEW PRISM CLINICAL IMAGING, INC. 510(k) NO: K122026(SPECIAL) ATTN: JAMES L REUSS PHONE NO : 262 754 3840 890 Elm Grove Rd., Suite 215 SE DECISION MADE: 21-SEP-12 Elm Grove WI 53122 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALMA LASERS FAMILY OF PIXEL RF TIPS ALMA LASERS INC. 510(k) NO: K121150(TRADITIONAL) ATTN: KATHY MAYNOR PHONE NO : 352 586 3113 485 HALF DAY RD. SUITW NO. 100 SE DECISION MADE: 21-SEP-12 BUFFALO GROVE IL 60089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASPIRE HD PLUS, ASPIRE HD-S FUJIFILM MEDICAL SYSTEM U.S.A., IN510(k) NO: K121674(TRADITIONAL) ATTN: PETER ALTMAN PHONE NO : 203 602 3576 419 WEST AVE. SE DECISION MADE: 21-SEP-12 STAMFORD CT 06902 6300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TROOPER OXYGEN CONCENTRATOR VBOX, INC. 510(k) NO: K121260(TRADITIONAL) ATTN: THEODORE JAGGER PHONE NO : 651 407 6206 2342 EAST COUNTY ROAD J SE DECISION MADE: 21-SEP-12 WHITE BEAR LAKE MN 55110 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CM MEDICAL COMPONENTS INC 510(k) NO: K121848(SPECIAL) ATTN: JEAN CALLOW PHONE NO : 215 256 4201 1499 DELP DRIVE SE DECISION MADE: 21-SEP-12 HARLEYSVILLE PA 19438 510(k) STATEMENT DEVICE: BIOMET MICROFIXATION FACIAL PLATING SYSTEM BIOMET MICROFIXATION 510(k) NO: K121589(SPECIAL) ATTN: LAUREN JASPER PHONE NO : 904 741 9259 1520 TRADEPORT DR. SE DECISION MADE: 21-SEP-12 JACKSONVILLE FL 32218 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIAZYME HSCRP POC TEST KIT DIAZYME LABORATORIES 510(k) NO: K121558(TRADITIONAL) ATTN: ABHIJIT DATTA PHONE NO : 858 455 4762 12889 GREGG COURT SE DECISION MADE: 21-SEP-12 POWAY CA 92064 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DALI SPINAL FIXATION SYSTEM ACCEL SPINE 510(k) NO: K121568(TRADITIONAL) ATTN: DANIEL CHON PHONE NO : 800 713 9489 14850 Quorum Dr Ste 220 SE DECISION MADE: 21-SEP-12 Dallas TX 75254 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AQUILION ONE VISION, V4.90 TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K122109(TRADITIONAL) ATTN: PAUL BIGGINS PHONE NO : 714 669 7808 2441 Michelle Dr SE DECISION MADE: 21-SEP-12 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLOOD PRESSURE MONITOR WITH STETHOSCOPE HANGZHOU RELI-ON CO., LTD 510(k) NO: K122259(TRADITIONAL) ATTN: CHARILE MACK PHONE NO : 931 625 4938 77325 JOYCE WAY SE DECISION MADE: 24-SEP-12 ECHO OR 97826 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE PL-1064 LASER SYSTEM SHEAUMANN LASER, INC 510(k) NO: K120938(TRADITIONAL) ATTN: TIMOTHY J SHEA PHONE NO : 407 590 2050 189 WINDING OAKS LANE SE DECISION MADE: 24-SEP-12 OVIEDO FL 32765 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INOMAX DS (DELIVERY SYSTEM) INO THERAPEUTICS 510(k) NO: K121021(TRADITIONAL) ATTN: DAVID TRUEBLOOD PHONE NO : 608 395 3910 2902 DAIRY DRIVE SE DECISION MADE: 24-SEP-12 MADISON WI 53718 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GEMINI LITHOTRIPTER DORNIER MEDTECH AMERICA, INC. 510(k) NO: K121656(SPECIAL) ATTN: JOHN HOFFER PHONE NO : 770 514 6163 1155 ROBERTS BLVD. SE DECISION MADE: 24-SEP-12 KENNESAW GA 30144 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LEW MDI O-BALL COLLARED IMPLANT, PARK DENTAL RESEARCH CORP. 510(k) NO: K121707(TRADITIONAL) ATTN: RONALD BULARD PHONE NO : 580 798 4418 2401 N Commerce St Ste B SE DECISION MADE: 24-SEP-12 Ardmore OK 73401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BENEHOLD CHG TRANSPARENT FILM DRESSING (10X12CM) (8.5X12CM) (6.5X7 CM) AVERY DENNISON BELGIE, BVBA 510(k) NO: K113836(TRADITIONAL) ATTN: JERZY WOJCIK PHONE NO : 312 629 4608 20N. WACKER DRIVE SUITE 2240 SE DECISION MADE: 24-SEP-12 CHICAGO IL 60606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST TIANJIN NEW BAY BIORESEARCH CO., L510(k) NO: K112449(TRADITIONAL) ATTN: HANN-PING WANG PHONE NO : 714 693 0301 5230 VIA PRIMARIA SE DECISION MADE: 24-SEP-12 YORBA LINDA CA 92886 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHF-Y0005 OLYMPUS MEDICAL SYSTEMS CORP. 510(k) NO: K113120(TRADITIONAL) ATTN: SHERI MUSGNUNG PHONE NO : 484 896 3147 3500 CORPORATE PARKWAY P.O. BOX 61SE DECISION MADE: 25-SEP-12 CENTER VALLEY PA 18034 0610 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTHREX SUTURE (UHMWPE) ARTHREX, INC. 510(k) NO: K122374(SPECIAL) ATTN: IVETTE GALMEZ PHONE NO : 239 643 5553 1370 CREEKSIDE BLVD. SE DECISION MADE: 25-SEP-12 NAPLES FL 34108 1945 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURELASE CO2 LASER SYSTEM CLINICON CORP. 510(k) NO: K121580(TRADITIONAL) ATTN: GERALD PALECKI PHONE NO : 760 715 5954 1107 259TH ST NW SE DECISION MADE: 25-SEP-12 STANWOOD WA 98292 4834 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZOLL R SERIES ZOLL MEDICAL CORPORATION, WORLD WI510(k) NO: K120907(TRADITIONAL) ATTN: CHARLES W KOLIFRATH PHONE NO : 978 421 9786 269 MILL ROAD SE DECISION MADE: 25-SEP-12 CHELMSFORD MA 01824 4105 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FAXITRON SPECIEN RADIOGRAPHY SYSTEM FAXITRON BIOPTICS LLC 510(k) NO: K122428(TRADITIONAL) ATTN: DOUGLAS C WIEGMAN PHONE NO : 847 276 3765 3440 E. BRITANNIA DRIVE SUITE 150 SE DECISION MADE: 25-SEP-12 TUCSON AZ 85706 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TOSHIBA 3T 32CH HEAD SPEEDER COIL, QUALITY ELECTRODYNAMICS 510(k) NO: K122638(TRADITIONAL) ATTN: KATHLEEN ARAS PHONE NO : 440 481 2964 700 BETA DRIVE SUITE 100 SE DECISION MADE: 25-SEP-12 MAYFIELD VILLAGE OH 44143 0000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BENCOX FORET & BENCOX DELTA CORENTEC CO., LTD 510(k) NO: K121665(TRADITIONAL) ATTN: J.S. DANIEL PHONE NO : 820 743933 819 11TH CHUNGHO TOWER 748-1 BANPO 1 DSE DECISION MADE: 25-SEP-12 SEOCHO GU, SEOUL KS 137-040 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATTAIN CLARITY 6225 VENOGRAM BALLOON CATHETER MEDTRONIC INC. 510(k) NO: K121219(TRADITIONAL) ATTN: WENDY SAUNDERS PHONE NO : 763 526 8134 8200 CORAL SEA STREET MS MVSII SE DECISION MADE: 25-SEP-12 MOUNDS VIEW MN 55112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DMRC NANOFLOW DMRC NANOCOMPOSITE EBOND SURE ETCH GEL SURE ETCH LIQUID DANVILLE MATERIALS, INC. 510(k) NO: K121880(TRADITIONAL) ATTN: LINDSAY TILTON PHONE NO : 925 973 0710 3420 FOSTORIA WAY, SUITE A-200 SE DECISION MADE: 25-SEP-12 SAN RAMON CA 94583 510(k) STATEMENT DEVICE: STERLING MEDICAL IMPULSE 3 STIMULATOR ARMSTRONG INDUSTRIES, INC. DHA MED510(k) NO: K121305(TRADITIONAL) ATTN: RALPH H ARMSTRONG PHONE NO : 972 547 1400 7290 VIRGINIA PARKWAY SUITE 3000 SE DECISION MADE: 25-SEP-12 MCKINNEY TX 75071 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CUSTOM CRANIOFACIAL IMPLANT (CCI) KELYNIAM GLOBAL, INC. 510(k) NO: K121755(TRADITIONAL) ATTN: NICHOLAS BREAULT PHONE NO : 800 280 8192 97 River Rd STE A SE DECISION MADE: 25-SEP-12 Canton CT 06019 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERRAD (R) 100NX DUO CYCLE TEST PACK ADVANCED STERILIZATION PRODUCTS 510(k) NO: K111391(TRADITIONAL) ATTN: NANCY CHU PHONE NO : 949 453 6435 33 TECHNOLOGY DR. SE DECISION MADE: 26-SEP-12 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXSPIRON RESPIRATORY MOTION, INC. 510(k) NO: K120087(TRADITIONAL) ATTN: CHAS BURR PHONE NO : 781 789 1646 11 MYSTIC AVENUE SE DECISION MADE: 26-SEP-12 WINCHESTER MA 01890 2920 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ITERATIVE RECONSTRUCTION TECHNIQUE SOFTWARE APPLICATION PHILIPS HEALTHCARE (CLEVELAND) 510(k) NO: K113483(TRADITIONAL) ATTN: CHRISTINE ANDERSON PHONE NO : 440 483 7732 595 MINER RD. SE DECISION MADE: 26-SEP-12 CLEVELAND OH 44143 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMBRYOGEN ORIGIO A/S 510(k) NO: K120136(TRADITIONAL) ATTN: ERIC GRUFF PHONE NO : 858 735 0320 15696 OAKSTAND ROAD SE DECISION MADE: 26-SEP-12 POWAY CA 92064 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROSOUND F37 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL: PROSOUND F37 HITACHI ALOKA MEDICAL, LTD. 510(k) NO: K122341(TRADITIONAL) ATTN: PHONE NO : 10 FAIRFIELD BLVD. SE DECISION MADE: 26-SEP-12 WALLINGFORD CT CT 06492 7502 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ATHEROEDGE ATHEROPOINT LLC 510(k) NO: K122022(TRADITIONAL) ATTN: JASJIT S SURI PHONE NO : 916 749 5628 208 OTTER GLEN CT SE DECISION MADE: 26-SEP-12 ROSEVILLE CA 95661 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COOLRAIL LINEAR PEN MODEL MCRI ATRICURE, INC. 510(k) NO: K122611(SPECIAL) ATTN: JIM LUCKY, RAC PHONE NO : 513 755 5754 6217 CENTRE PARK DRIVE SE DECISION MADE: 26-SEP-12 WEST CHESTER OH 45069 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DURABLUE STERILIZATION WRAP, MODEL NUMBERS CH100, CH200, CH300, CH400, CH500 AND CH600, STERRAD NX STERILIZATION CARDINAL HEALTH 200, LLC 510(k) NO: K122507(TRADITIONAL) ATTN: LAVENIA FORD PHONE NO : 847 887 3323 1430 WAUKEGAN ROAD SE DECISION MADE: 26-SEP-12 WAUKEGAN IL 60085 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ELECTRONIC STETHOSCOPE SHARP CORPORATION 510(k) NO: K121144(TRADITIONAL) ATTN: DIANE RUTHERFORD PHONE NO : 972 480 9554 1201 RICHARDSON DRIVE SUITE 280 SE DECISION MADE: 26-SEP-12 RICHARDSON TX 75080 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORACLE LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM ACCEL SPINE 510(k) NO: K121567(TRADITIONAL) ATTN: DANIEL CHON PHONE NO : 800 713 9489 14850 Quorum Dr Ste 220 SE DECISION MADE: 26-SEP-12 Dallas TX 75254 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHORT LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT MODEL 3017-000 (LEFT) AND 3018-000 (RIGHT); 6 HOLE MEDIUM MIDSHAFT ADVANCED ORTHOPAEDIC SOLUTIONS, IN510(k) NO: K122623(SPECIAL) ATTN: ALLYSON PARKS PHONE NO : 310 533 9966 386 BEECH AVENUE UNIT B6 SE DECISION MADE: 26-SEP-12 TORRANCE CA 90501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FREEDOM ND: YAG LASER SYSTEM LUTRONIC CORPORATION 510(k) NO: K113843(TRADITIONAL) ATTN: JHUNG WON VOJIR PHONE NO : 215 205 2219 6 NESHAMINY INTERPLEX, SUITE 207 SE DECISION MADE: 27-SEP-12 TREVOSE PA 19053 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RAPICIDE OPA-28 MINNTECH CORP. 510(k) NO: K120306(TRADITIONAL) ATTN: BRENT GREIGER, MS, RAC PHONE NO : 763 553 3300 14605 28TH AVE. NORTH SE DECISION MADE: 27-SEP-12 MINNEAPOLIS MN 55447 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM CONFORMIS, INC. 510(k) NO: K122033(TRADITIONAL) ATTN: AMITA S SHAH PHONE NO : 781 345 9164 11 NORTH AVENUE SE DECISION MADE: 27-SEP-12 BURLINGTON MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EASYONE PRO RESPIRATORY TESTING DEVICE NDD MEDIZITECHNIK AG 510(k) NO: K120635(TRADITIONAL) ATTN: GERARD MASIELLO PHONE NO : 978 470 0923 TWO DUNDEE PARK SE DECISION MADE: 27-SEP-12 ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TYPE 1077 ACCUSCREEN GN OTOMETRICS 510(k) NO: K122067(TRADITIONAL) ATTN: TOM RINIKER PHONE NO : 612 865786 2 HOERSKAETTEN 9 SE DECISION MADE: 27-SEP-12 TAATRUP DA DK-2630 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SUPER SHEATH INTRODUCER SHEATH AND SUPER SHEATH INTRODUCER SHEATH SETS TOGO MEDIKIT CO., LTD. 510(k) NO: K121504(TRADITIONAL) ATTN: HEATHER CRAWFORD PHONE NO : 512 327 9997 611 WEST 5TH STREET SE DECISION MADE: 27-SEP-12 AUSTIN TX 78701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WITHINGS, SMART BODY SCALE ZHONGSHAN TRANSTEK ELECTRONICS CO.510(k) NO: K121971(SPECIAL) ATTN: LEO WANG PHONE NO : 862 886 083300 NO. 1 FANGHUA STREET HI-TECH DISTRSE DECISION MADE: 27-SEP-12 CHENGDU, SICHUAN CH 610041 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PMT BONE SCREWS PROVIDENCE MEDICAL TECHNOLOGY, INC510(k) NO: K121713(TRADITIONAL) ATTN: GLEN MANGSETH PHONE NO : 415 923 9376 201 Spear St Ste 1310 SE DECISION MADE: 27-SEP-12 San Francisco CA 94105 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KARL STORZ NAVIGATIONPANEL UNIT (NPU) SYSTEM KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K122096(TRADITIONAL) ATTN: LEIGH SPOTTEN PHONE NO : 424 218 8738 2151 E. GRAND AVE. SE DECISION MADE: 27-SEP-12 EL SEGUNDO CA 90245 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) SHANDONG JUNFENG INDUSTRIES CO., L510(k) NO: K122266(TRADITIONAL) ATTN: CHU XIAOAN PHONE NO : 861 082 387441 ROOM 1606 BLDG. 1. JIANXIANG YUAN SE DECISION MADE: 27-SEP-12 BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PEERSCOPE SYSTEM PEERMEDICAL 510(k) NO: K120289(TRADITIONAL) ATTN: DAN LAOR PHONE NO : 972 482 46632 6 SIRENI SE DECISION MADE: 28-SEP-12 HAIFA IS 32972 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BAUSCH & LOMB IOL INJECTOR BAUSCH & LOMB, INC. 510(k) NO: K113852(TRADITIONAL) ATTN: JASON SMITH PHONE NO : 800 393 6642 30 ENTERPRISE SUITE 450 SE DECISION MADE: 28-SEP-12 ALISO VIEJO CA 92656 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET NIPRO MEDICAL CORPORATION 510(k) NO: K112628(SPECIAL) ATTN: JESSICA OSWALD PHONE NO : 305 599 7174 3150 N.W. 107TH AVE. SE DECISION MADE: 28-SEP-12 MIAMI FL 33172 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MPACT EXTENSION MEDACTA INTERNATIONAL 510(k) NO: K122641(SPECIAL) ATTN: ADAM GROSS PHONE NO : 805 437 7085 4725 CALLE QUETZAL, UNIT B SE DECISION MADE: 28-SEP-12 CAMARILLO CA 93012 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL EYE-FUNDUS CAMERA MEDIMAGING INTEGRATED SOLUTIONS, I510(k) NO: K120982(TRADITIONAL) ATTN: CHIH-LU HSU PHONE NO : 886 357 98860 1F, NO. 7, R&D RD II HSUNCHU SCIENSE DECISION MADE: 28-SEP-12 HSINCHU CH 30076 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WALLFLEXTM BILIARY RX STENT SYSTEM (UNCOVERED, PARTIALLY COVERED, AND FULLY COVERED) WALLFLEXTM BILIARY TRANSHEPATIC STE BOSTON SCIENTIFIC CORPORATION 510(k) NO: K122072(TRADITIONAL) ATTN: LAURIE PANNELLA PHONE NO : 508 683 4872 100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 28-SEP-12 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOMNOGUARD SP SOFT TOMED DR. TOUSSAINT GMBH 510(k) NO: K121761(TRADITIONAL) ATTN: SCOTT WHITCOMB PHONE NO : 603 968 3172 854 US ROUTE 3 SE DECISION MADE: 28-SEP-12 HOLDERNESS NH 03245 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EPIC 10 BIOLASE TECHNOLOGY, INC. 510(k) NO: K121286(SPECIAL) ATTN: ROBERT YANG PHONE NO : 949 361 1200 4 CROMWELL SE DECISION MADE: 28-SEP-12 IRVINE CA 92618 1816 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUSON SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K122825(TRADITIONAL) ATTN: SHELLY PEARCE PHONE NO : 650 694 5988 685 East Middlefield Road SE DECISION MADE: 28-SEP-12 Mountain View CA 94043 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: EXACTRAC VERO BRAINLAB AG 510(k) NO: K122451(TRADITIONAL) ATTN: ALEXANDER SCHWIERSCH PHONE NO : 004 989 9915680 KAPELLENSTRASSE 12 SE DECISION MADE: 28-SEP-12 FELDKIRCHEN GM 85622 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GMK NARROW MEDACTA INTERNATIONAL 510(k) NO: K122232(SPECIAL) ATTN: ADAM GROSS PHONE NO : 805 437 7085 4725 CALLE QUETZAL, UNIT B SE DECISION MADE: 28-SEP-12 CAMARILLO CA 93012 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 14.5-16.0 FRENCH CUFFED CATHETER REMOVAL DEVICE, SYMMETRY SURGICAL SINGEL USE SYMMETRY MEDICAL 510(k) NO: K122263(TRADITIONAL) ATTN: HANNAH FOLEY PHONE NO : 615 964 5509 3034 OWEN DRIVE SE DECISION MADE: 28-SEP-12 ANTIOCH TN 37013 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BRIGHT RESTORATIVE MATERIALS DMP LTD 510(k) NO: K121915(TRADITIONAL) ATTN: DIMITRIS PRANTSIDIS PHONE NO : 003 022990 23041 KALYVION AVENUE MARKOPOULO INDUSTRSE DECISION MADE: 28-SEP-12 MARKOPOULO, ATTIKI GR 19003 510(k) STATEMENT DEVICE: OVERTUBE ENDOSCOPIC ACCESS SYSTEM APOLLO ENDOSURGERY, INC. 510(k) NO: K122270(TRADITIONAL) ATTN: HEATHER CRAWFORD, RAC PHONE NO : 512 328 9990 7000 BEE CAVES RD. SUITE 350 SE DECISION MADE: 28-SEP-12 AUSTIN TX 78746 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K122433(SPECIAL) ATTN: CHRIS MCKEE PHONE NO : 901 396 3133 1800 PYRAMID PLACE SE DECISION MADE: 28-SEP-12 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BESIDE RESPIRATORY PATIENT MONITORING SYSTEM BESIDE RESIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTWARE COVIDIEN 510(k) NO: K121806(ABBREVIATED) ATTN: ELIZABETH MALO PHONE NO : 303 305 2763 6135 GUNBARREL AVE. SE DECISION MADE: 28-SEP-12 BOULDER CO 80301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EZ-BLOCKER EZ-BLOCKER B.V. 510(k) NO: K121462(TRADITIONAL) ATTN: LEWIS WARD PHONE NO : 303 530 3279 4655 KIRKWOOD COURT SE DECISION MADE: 28-SEP-12 BOULDER CO 80301 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 246 TOTAL WITH SUMMARIES 238 TOTAL WITH STATEMENTS 8
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