Medical Devices
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January 2013 510(k) Clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD January 2013 DEVICE: DIGITAL FLAT PANEL X-RAY DETECTOR11417PCA RAYENCE CO., LTD 510(k) NO: K122919(TRADITIONAL) ATTN: DAVE KIM PHONE NO : 713 467 2607 12946 KIMBERLEY LN SE DECISION MADE: 01-JAN-13 HOUSTON TX 77079 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT DIASORIN, INC. 510(k) NO: K121944(TRADITIONAL) ATTN: MARI MEYER PHONE NO : 651 439 9710 1951 NORTHWESTERN AVE. P.O. BOX 28SE DECISION MADE: 01-JAN-13 STILLWATER MN 55082 0285 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE INNOVA/INNOVA IGS/DISCOVERY IGS/OPTIMA ANGIOGRAPHIC, FLUOSCOPIC X-RAY SYSTEMS WITH CATHLAB FRONTIERS SOLUTIONS GE HEALTHCARE 510(k) NO: K122457(TRADITIONAL) ATTN: MALCA PHONE NO : 003 364 6373852 283, RUE DE LA MINIERE SE DECISION MADE: 02-JAN-13 BUC FR 78530 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN SURGICAL SPECIALTIES CORP. DBA ANG510(k) NO: K123877(SPECIAL) ATTN: KIRSTEN STOWELL PHONE NO : 610 404 3367 100 DENNIS DR. SE DECISION MADE: 02-JAN-13 Reading PA 19606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTERVENTIONAL WORKSPOT PHILIPS MEDICAL SYSTEMS NEDERLAND 510(k) NO: K121296(TRADITIONAL) ATTN: FRANS JACOBS PHONE NO : 314 027 99709 VEENPLUIS 4-6 SE DECISION MADE: 02-JAN-13 BEST NL 5684 PC 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENS MENICON CO. LTD. 510(k) NO: K122273(ABBREVIATED) ATTN: ELLEN M BEUCLER PHONE NO : 978 658 6888 187 BALLARDVALE STREET SUITE 180 SE DECISION MADE: 02-JAN-13 WILMINGTON MA 01887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRACKER-17 MICROCATHER, 150 CM LONG AND 15.0 CM FLEXIBLE DISTAL SHAFT, TRACKER-17 MICROCATHETER, 150 CM LONG AND 7.5 CM STRYKER 510(k) NO: K123452(SPECIAL) ATTN: JEAN CHEN PHONE NO : 510 413 2591 47900 BAYSIDE PARKWAY SE DECISION MADE: 03-JAN-13 FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COLLADENTAL BARRIER COLLAMATRIX, INC 510(k) NO: K100695(TRADITIONAL) ATTN: DENNIS J. N. SEAH PHONE NO : 886 277 113299 26F, NO. 105, SECTION 2 DUNHUA SOUSE DECISION MADE: 03-JAN-13 TAIPEI TW 106 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUPER STAPLE(TM) CLASSIC METRIC MEDICAL DEVICES, INC. 510(k) NO: K123363(TRADITIONAL) ATTN: W CASEY FOX PHD PE PHONE NO : 830 535 6300 846 SILVER SPRINGS SE DECISION MADE: 03-JAN-13 HELOTES TX 78023 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOVEREIGN MINI AESCULAP, INC. 510(k) NO: K123102(SPECIAL) ATTN: DENISE ADAMS PHONE NO : 610 984 9076 3773 CORPORATE PARKWAY SE DECISION MADE: 03-JAN-13 CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOPHOTAS LIFELIGHT BIOPHOTAS, INC. 510(k) NO: K122237(TRADITIONAL) ATTN: SHEPARD G BENTLEY, RAC PHONE NO : 949 495 4274 28241 CROWN VALLEY PARKWAY, SUITE SE DECISION MADE: 03-JAN-13 LAGUNA NIGUEL CA 92677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DOPPLEX ABILITY HUNTLEIGH HEALTHCARE 510(k) NO: K121108(TRADITIONAL) ATTN: DAVID MOYNHAM PHONE NO : 442 920 485885 35 PORTMANMOOR ROAD SE DECISION MADE: 03-JAN-13 CARDIFF UK CF24 5HN 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RETRACTA DETACHABLE EMBOLIZATION COIL COOK INCORPORATED 510(k) NO: K123712(SPECIAL) ATTN: JENNIFER RICHARDSON PHONE NO : 812 339 2235 750 DANIELS WAY SE DECISION MADE: 03-JAN-13 BLOOMINGTON IN 47402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEO ERCP GUIDEWIRE NEOMETRICS, INC. 510(k) NO: K123439(TRADITIONAL) ATTN: GENE CHAMPEAU PHONE NO : 763 559 4440 2605 FERNBROOK LANE N. SUITE J SE DECISION MADE: 03-JAN-13 PLYMOUTH MN 55447 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGER MOOR INSTRUMENTS LTD. 510(k) NO: K122943(TRADITIONAL) ATTN: STEWART LILLINGTON PHONE NO : 441 297357 15 MILLWEY SE DECISION MADE: 03-JAN-13 AXMINSTER, DEVON UK EX135HU 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JUNCTIONAL EMERGENCY TREATMENT TOOL MODEL 30-0088 NORTH AMERICAN RESCUE PRODUCTS, IN510(k) NO: K123194(TRADITIONAL) ATTN: WILLIAM SLEVIN PHONE NO : 864 675 9800 35 TEDWALL COURT SE DECISION MADE: 03-JAN-13 GREER SC 29650 4791 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PEARL DIABETES MANAGEMENT SYSTEM ASANTE SOLUTIONS, INC. 510(k) NO: K122483(SPECIAL) ATTN: ROBIN BUSH PHONE NO : 408 716 5600 352 E Java Dr SE DECISION MADE: 03-JAN-13 Sunnyvale CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CG+ ARROW PICC POWERED BY ARROW VPS STYLET ARROW INTERNATIONAL, INC. (SUBSIDI510(k) NO: K123759(SPECIAL) ATTN: ELIZABETH DUNCAN PHONE NO : 610 378 0131 2400 Bernville Road SE DECISION MADE: 03-JAN-13 Reading PA 19605 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AIRVO HUMIDIFIER MYAIRO HUMIDIFIER FISHER & PAYKEL HEALTHCARE, LTD. 510(k) NO: K121975(TRADITIONAL) ATTN: BRETT WHISTON PHONE NO : 649 574 0100 15 MAURICE PAYKEL PLACE EAST TAMAKSE DECISION MADE: 03-JAN-13 ACKLAND NZ 2013 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES DEFIBTECH, LLC 510(k) NO: K113787(TRADITIONAL) ATTN: ED HORTON PHONE NO : 203 453 6654 741 BOSTON POST ROAD,SUITE 201 SE DECISION MADE: 04-JAN-13 GUILFORD CT 06437 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BODY FAT SCALE MODEL SF-371 SHENZHEN BELTER HEALTH MEASUREMENT510(k) NO: K122976(TRADITIONAL) ATTN: CHARLIE MACK PHONE NO : 931 625 4938 77325 JOYCE WAY SE DECISION MADE: 04-JAN-13 ECHO OR 97826 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OLYMPUS MAJ-172 INSTRUMENT TRAY FOR LTF VIDEOSCOPE OLYMPUS KEYMED (MEDICAL & INDUSTRI510(k) NO: K122818(TRADITIONAL) ATTN: RONALD S WARREN PHONE NO : 858 753 1961 11440 WEST BERNARDO DRIVE SUITE 30SE DECISION MADE: 04-JAN-13 SAN DIEGO CA 92127 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER ARROW INTERNATIONAL(SUBSIDIARY OF 510(k) NO: K122854(TRADITIONAL) ATTN: JULIE LAWSON PHONE NO : 610 378 0131 2400 BERNVILLE RD. SE DECISION MADE: 04-JAN-13 READING PA 19605 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THERASOM-CAST FAMILY DENTAL SERVICES, P.C. 510(k) NO: K113516(TRADITIONAL) ATTN: DEANNA L BAXAM PHONE NO : 678 896 1986 2180 SATELLITE BOULEVARD SUITE 400SE DECISION MADE: 04-JAN-13 DULUTH GA 30097 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSTINCT JAVA SYSTEM ZIMMER SPINE 510(k) NO: K122592(TRADITIONAL) ATTN: ELSA A LINKE PHONE NO : 952 830 6205 7375 BUSH LAKE ROAD SE DECISION MADE: 04-JAN-13 EDINA MN 55439 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY GLAXOSMITHKLINE CONSUMER HEALTHCAR510(k) NO: K123731(SPECIAL) ATTN: PAUL KRUMM PHONE NO : 973 889 7339 1500 LITTLETON ROAD SE DECISION MADE: 04-JAN-13 PARSIPPANY NJ 07054 510(k) STATEMENT DEVICE: K7C SPACER K7 LLC 510(k) NO: K123388(TRADITIONAL) ATTN: KARREN E WARDEN, PHD PHONE NO : 440 729 8457 PO BOX 566 SE DECISION MADE: 04-JAN-13 CHESTERLAND OH 44026 2141 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VANTAGE MODEL V5000, V5100, V5000C, V5100C MIDMARK CORP. 510(k) NO: K122643(TRADITIONAL) ATTN: MARK GREENWOOD PHONE NO : 847 415 9800 675 HEATHROW DRIVE SE DECISION MADE: 07-JAN-13 LINCOLNSHIRE IL 60069 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TS IMPLANT SYSTEM OSSTEM IMPLANT CO.,LTD 510(k) NO: K121585(TRADITIONAL) ATTN: PATRICK LIM PHONE NO : 888 678 0001 85 BEN FAIRLESS DR. SE DECISION MADE: 07-JAN-13 FAIRLESS HILLS PA 19030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BRAINSWAY DEEP TMS SYSTEM BRAINSWAY, LTD 510(k) NO: K122288(TRADITIONAL) ATTN: AHAVA STEIN PHONE NO : 972 976700 02 20 HATA'AS ST. (POB 124) SE DECISION MADE: 07-JAN-13 KFAR SABA IS 44425 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AVIE TOTAL HB TEST SYSTEM MEC DYNAMICS CORP 510(k) NO: K121752(TRADITIONAL) ATTN: EMMANUAL MPOCK PHONE NO : 408 428 9721 90 ROSE ORCHARD WAY SE DECISION MADE: 07-JAN-13 SAN JOSE CA 95134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENTEROCOCCUS QUICKFISH BC ADVANDX, INC. 510(k) NO: K121991(TRADITIONAL) ATTN: BENJAMIN S CRYSTAL PHONE NO : 781 376 0009 400 TRADECENTER SUITE 6990 SE DECISION MADE: 07-JAN-13 WOBURN MA 01801 510(k) STATEMENT DEVICE: MEGA 5.5 SPINE SYSTEM LSK BIOPARTNERS, INC. 510(k) NO: K123476(TRADITIONAL) ATTN: SHIN KUK YOO PHONE NO : 714 313 7442 8 EAST BROADWAY, STE 611 SE DECISION MADE: 08-JAN-13 SALT LAKE CITY UT 84111 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COLLAGEN TENDON SHEET-D ROTATION MEDICAL, INC. 510(k) NO: K122048(TRADITIONAL) ATTN: JEFF SIMS PHONE NO : 763 746 7502 15350 25TH AVENUE N SUITE 100 SE DECISION MADE: 08-JAN-13 PLYMOUTH MN 55447 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET BAXTER HEALTHCARE CORP. 510(k) NO: K123868(SPECIAL) ATTN: GARY CHUMBIMUNE PHONE NO : 224 270 3312 32650 N WILSON RD. SE DECISION MADE: 08-JAN-13 ROUND LAKE IL 60073 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FALCON SPACER SYNTHES (USA) PRODUCTS LLC 510(k) NO: K123180(TRADITIONAL) ATTN: MONIKA MCDOLE-RUSSELL PHONE NO : 610 719 5424 1302 WRIGHTS LANE EAST SE DECISION MADE: 08-JAN-13 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASAP MUITISCOPE ASAP ENDOSCOPIC PRODUCTS GMBH 510(k) NO: K121261(TRADITIONAL) ATTN: ANGELIKA SCHERP PHONE NO : 312 061 15626 AMSTEL 320-I SE DECISION MADE: 08-JAN-13 AMSTERDAM NL 1017AP 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MALLEABLE TIP ENDOSCOPIC APPLICATOR MICROMEDICS, INC. 510(k) NO: K123847(SPECIAL) ATTN: JODI L RAUS PHONE NO : 651 452 1977 1270 EAGAN INDUSTRIAL ROAD SUITE 1SE DECISION MADE: 08-JAN-13 Saint Paul MN 55121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALIGNRT PLUS VISION RT LIMITED 510(k) NO: K123371(TRADITIONAL) ATTN: NORMAN SMITH PHONE NO : 44 020 83464300 Dove House Arcadia Avenue SE DECISION MADE: 08-JAN-13 LONDON GB N3 2JU 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOLOCEM COLTENE/WHALEDENT AG 510(k) NO: K121621(TRADITIONAL) ATTN: SILKE WALLASCHEK PHONE NO : 410 717575 852 FELDWIESENSTRASSE 20 SE DECISION MADE: 08-JAN-13 ALTSTATTEN SZ CH-9450 510(k) STATEMENT DEVICE: AEQUALIS ASCEND FLEX SHOULDER SYSTEM TORNIER SAS 510(k) NO: K122698(TRADITIONAL) ATTN: BRAHIM HADRI PHONE NO : 781 249 8030 10801 NESBITT AVENUE SOUTH SE DECISION MADE: 08-JAN-13 BLOOMINGTON MN 55437 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Q-FIX SUTURE ANCHOR, 1.8MM Q-FIX ACCESS TOOLS (DRILL GUIDE W/OBTURATOR, DRILL BIT) 1.8MM ELEVEN BLADE SOLUTIONS, INC. 510(k) NO: K122336(TRADITIONAL) ATTN: MICHAEL KOLBER PHONE NO : 408 505 6626 14734 LA RINCONADA DRIVE SE DECISION MADE: 09-JAN-13 LOS GATOS CA 95032 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LUMINEX FLEXMAP 3D INSTRUMENT SYSTEM, LUMINEX XPONENT 4.0 SPI SOFTWARE, FLEXMAP 3D IVD CALIBRATION KIT, FLEXMAP 3D IVD P LUMINEX CORP. 510(k) NO: K121399(TRADITIONAL) ATTN: OLIVER MEEK PHONE NO : 512 219 8020 12212 Technology Blvd SE DECISION MADE: 09-JAN-13 AUSTIN TX 78727 510(k) STATEMENT DEVICE: AFFINITY FUSION CARDIOTOMY/VENOUS RESERVIOR WITH BALANCE BIOSURFACE MODEL BB841, AFFINITY FUSION CARDIOTOMY/ VENOUS RESE MEDTRONIC INC. 510(k) NO: K122914(TRADITIONAL) ATTN: JULIA A NELSON PHONE NO : 763 514 9844 7611 NORTHLAND DRIVE SE DECISION MADE: 09-JAN-13 MINNEAPOLIS MN 55428 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIQUIDCHEK DIABETES CONTROL; LEVEL 1, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK BIO-RAD LABORATORIES 510(k) NO: K123798(TRADITIONAL) ATTN: SUZANNE PARSONS PHONE NO : 949 598 1467 9500 JERONIMO RD. SE DECISION MADE: 09-JAN-13 IRVINE CA 92618 2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BEST LOCALIZATION NEEDLE WITH I-125 SEED BEST MEDICAL INTL. 510(k) NO: K122704(TRADITIONAL) ATTN: DHARMENDRA THAKUR PHONE NO : 703 451 2378 7643 FULLERTON ROAD SE DECISION MADE: 09-JAN-13 SPRINGFIELD VA 22153 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRYKER CROSSFLOW ARTHROSCOPY PUMP STRYKER ENDOSCOPY 510(k) NO: K123441(TRADITIONAL) ATTN: KEVIN POTGIETER PHONE NO : 408 754 2000 5900 OPTICAL CT. SE DECISION MADE: 09-JAN-13 SAN JOSE CA 95138 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE BECTON DICKINSON & CO. 510(k) NO: K123213(TRADITIONAL) ATTN: JOHN ROBERTS PHONE NO : 201 847 5473 1 BECTON DR. MC237 SE DECISION MADE: 09-JAN-13 FRANKLIN LAKES NJ 07417 1885 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER GEN-PROBE, INC. 510(k) NO: K122062(TRADITIONAL) ATTN: MARIA CARMELITA S BALUYOT PHONE NO : 858 410 8309 10210 GENETIC CENTER DR. SE DECISION MADE: 09-JAN-13 SAN DIEGO CA 92121 4362 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MERITS MODEL P322FWD POWERED WHEELCHAIR MERITS HEALTH PRODUCTS CO., LTD. 510(k) NO: K122357(ABBREVIATED) ATTN: STEVE CHAO PHONE NO : 886 4 2359X200 NO.18 JINGKE RD. NANTUN DIST SE DECISION MADE: 09-JAN-13 TAICHUNG TW 40852 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRANSTEK GLASS BODY FAT ANALYZER ZHONGSHAN TRANSTEK ELECTRONICS CO.510(k) NO: K123781(SPECIAL) ATTN: LEO WANG PHONE NO : 086 28 86083300 NO. 1 FANGHUA STREET HI-TECH DISTRSE DECISION MADE: 09-JAN-13 CHENGDU, SICHUAN CH 610041 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS UCP BIOSCIENCES, INC. 510(k) NO: K123863(SPECIAL) ATTN: NANCY CHEN PHONE NO : 408 392 0064 1445 KOLL CIRCLE, STE. 111 SE DECISION MADE: 09-JAN-13 SAN JOSE CA 95112 510(k) STATEMENT DEVICE: SENOMARK ULTRA BREAST TISSUE MARKER C.R. BARD, INC. 510(k) NO: K123911(SPECIAL) ATTN: SARAH MCCARTNEY PHONE NO : 480 638 2954 1625 WEST 3RD ST. SE DECISION MADE: 10-JAN-13 TEMPE AZ 85281 1740 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EC SINGLE USE, POLYPECTOMY SNARE ENDOCHOICE, INC. 510(k) NO: K123223(TRADITIONAL) ATTN: SHOSHANA FRIEDMAN PHONE NO : 704 899 0092 1914 J.N. PEASE PLACE SE DECISION MADE: 10-JAN-13 CHARLOTTE NC 28262 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLOOD CULTURE HOLDER GREINER BIO-ONE NORTH AMERICA, INC510(k) NO: K122687(TRADITIONAL) ATTN: JUDI SMITH PHONE NO : 410 592 2060 P.O. BOX 103 SE DECISION MADE: 10-JAN-13 BALDWIN MD 21013 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPINAL ELEMENTS CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM SPINAL ELEMENTS, INC. 510(k) NO: K122771(TRADITIONAL) ATTN: BENJAMIN A KIMBALL PHONE NO : 760 607 1816 2744 LOKER AVE. W. SUITE 100 SE DECISION MADE: 10-JAN-13 CARLSBAD CA 92010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AQUAMANTYS ENDO DBS 8.7 DISSECTING BIPOLAR SEALER MEDTRONIC ADVANCED ENERGY, LLC 510(k) NO: K123201(TRADITIONAL) ATTN: JANET KWIATKOWSKI PHONE NO : 603 842 6283 180 INTERNATIONAL DRIVE SE DECISION MADE: 10-JAN-13 Portsmouth NH 03801 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEW COMFORT-FIT DENTAL GUARD DENTEK ORAL CARE, INC. 510(k) NO: K123849(SPECIAL) ATTN: LINDA GILES PHONE NO : 865 983 1300 307 EXCELLENCE WAY SE DECISION MADE: 10-JAN-13 MARYVILLE TN 37801 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL S BAXTER HEALTHCARE CORP. 510(k) NO: K123874(SPECIAL) ATTN: NANETTE HEDDEN PHONE NO : 224 270 4871 32650 N WILSON RD. SE DECISION MADE: 10-JAN-13 ROUND LAKE IL 60073 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: I.FLEX BY TCS THERMOPLASTIC COMFORT SYSTEMS, INC510(k) NO: K123396(TRADITIONAL) ATTN: MARLIN POSCA PHONE NO : 526 426 2970 2619 LIME AVENUE SE DECISION MADE: 10-JAN-13 SIGNAL HILL CA 90755 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XENX STONE MANAGEMENT DEVICE XENOLITH MEDICAL 510(k) NO: K123438(SPECIAL) ATTN: OFER ZIGMAN PHONE NO : 972 8 6811761 Leshem 1 SE DECISION MADE: 10-JAN-13 Kiryat Gat IL 82000 510(k) STATEMENT DEVICE: OPTETRAK LOGIC CRC TIBIAL INSERT EXACTECH, INC. 510(k) NO: K123342(SPECIAL) ATTN: PATRICK HUGHES PHONE NO : 352 327 4762 2320 N.W. 66TH CT. SE DECISION MADE: 10-JAN-13 GAINESVILLE FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: E-BEAM ND: YAG LASER ECLIPSE AESTHETICS, LLC 510(k) NO: K122922(TRADITIONAL) ATTN: TOM OBRIEN PHONE NO : 972 380 2911 13998 DIPLOMAT DRIVE SE DECISION MADE: 10-JAN-13 DALLAS TX 75234 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRYO-TOUCH IV MYOSCIENCE INC 510(k) NO: K123516(TRADITIONAL) ATTN: TRACEY HENRY PHONE NO : 650 474 2600 1600 SEAPORT BLVD, STE 450 NORTH LSE DECISION MADE: 10-JAN-13 REDWOOD CITY CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DETECT FORUM ENGINEERING TECHNOLOGIES LTD510(k) NO: K121206(TRADITIONAL) ATTN: YULIYA YUKEVICH PHONE NO : 972 396255 17 1 PLATIN ST, NEW INDUSTRIAL ZONE SE DECISION MADE: 10-JAN-13 RISHON LEZION IS 75653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EVIS EXERA III VIDEO SYSTEM OLYMPUS MEDICAL SYSTEMS CORP. 510(k) NO: K121959(TRADITIONAL) ATTN: LAURA STORMS-TYLER PHONE NO : 484 896 5688 3500 CORPORATE PARKWAY PO BOX 610 SE DECISION MADE: 10-JAN-13 CENTER VALLY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ME SYNERON BEAUTY LTD. 510(k) NO: K123845(SPECIAL) ATTN: JANICE M HOGAN PHONE NO : 267 675 4611 1835 MARKET ST., 29TH FLOOR SE DECISION MADE: 10-JAN-13 PHILADELPHIA PA 19103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EM3 AEM MONITOR AEM CONNECTORS ENCISION, INC. 510(k) NO: K122383(TRADITIONAL) ATTN: JIM LEWIS PHONE NO : 303 444 2600 6797 WINCHESTER CIR. SE DECISION MADE: 10-JAN-13 BOULDER CO 80301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDTRONIC XOMED, INC. MEDTRONIC XOMED, INC. 510(k) NO: K122391(TRADITIONAL) ATTN: DOUGLAS JOHNSON PHONE NO : 904 286 9600 6743 SOUTHPOINT DR. NORTH SE DECISION MADE: 10-JAN-13 JACKSONVILLE FL 32216 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MANOMETER INTERSURGICAL, INC. 510(k) NO: K122077(TRADITIONAL) ATTN: MICHAEL ZALEWSKI PHONE NO : 315 451 2900 417 ELECTRONICS PKWY. SE DECISION MADE: 10-JAN-13 LIVERPOOL NY 13088 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SCULPTOR ROBOTIC GUIDANCE ARM (RGA) STANMORE IMPLANTS WORLDWIDE LTD 510(k) NO: K121765(TRADITIONAL) ATTN: HOLLACE SAAS RHODES PHONE NO : 202 552 5807 1331 H STREET, NW, 12 FLOOR SE DECISION MADE: 11-JAN-13 WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INFRASCANNER INFRASCAN, INC. 510(k) NO: K120949(TRADITIONAL) ATTN: STEVEN B DATLOF, M.D., J.D. PHONE NO : 267 675 4613 1835 MARKET ST., 29TH FLOOR SE DECISION MADE: 11-JAN-13 PHILADELPHIA PA 19103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PATIENT MONITOR MODELS PM-2000A, PM-2000A+, PM-2000A PRO ADVANCED INSTRUMENTATIONS, INC. 510(k) NO: K123048(TRADITIONAL) ATTN: JORGE MILLAN PHONE NO : 305 925 1260 601 WEST 20TH STREET SE DECISION MADE: 11-JAN-13 HIALEAH FL 33010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPECBOARD JR. MACBRUD CORP., MEDICAL DIVISION 510(k) NO: K123414(TRADITIONAL) ATTN: TODD LARY PHONE NO : 305 378 1958 14021 SW 143 COURT, UNIT 6 SE DECISION MADE: 11-JAN-13 MIAMI FL 33186 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IB CLINIC IMAGING BIOMETRICS, LLC 510(k) NO: K123302(TRADITIONAL) ATTN: MIKE SCHMAINDA PHONE NO : 262 439 8252 13416 Watertown Plank Rd Suite 260SE DECISION MADE: 11-JAN-13 Elm Grove WI 53122 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AFFIRM BREAST BIOPSY GUIDANCE SYSTEM LORAD, A HOLOGIC CO. 510(k) NO: K122836(SPECIAL) ATTN: GAIL YAEKER-DAUNIS PHONE NO : 203 731 8337 36 APPLE RIDGE RD. SE DECISION MADE: 11-JAN-13 DANBURY CT 06810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MTF NEW BONE VOID FILLER MUSCULOSKELETAL TRANSPLANT FOUNDAT510(k) NO: K121313(TRADITIONAL) ATTN: NANCY JOY PHONE NO : 732 661 2381 125 MAY STREET SE DECISION MADE: 11-JAN-13 EDISON NJ 08837 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIZION + DR VIZTEK LLC 510(k) NO: K123644(SPECIAL) ATTN: DANIEL KAMM, P.E. PHONE NO : 239 234 1735 8870 RAVELLO CT SE DECISION MADE: 11-JAN-13 NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAMBER SPINE TECHNOLOGIES TLS 5.0 INERBODY CAGE CAMBER SPINE TECHNOLOGIES 510(k) NO: K121254(TRADITIONAL) ATTN: DAN PONTECORVO PHONE NO : 484 420 4671 401 YANKEE COURT SE DECISION MADE: 11-JAN-13 NEWTOWN SQUARE PA 19073 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WA SERIES: WA100; WA200; WD100; WE100, WF100; WB200 NINGBO DIAIER ELECTRONIC CO., LTD.510(k) NO: K123839(SPECIAL) ATTN: LAO XIKUN PHONE NO : 86 0574 62463008 YAOXI INDUSTRIAL ZONE SE DECISION MADE: 11-JAN-13 YUYAO CITY, ZHEJIANG CH 315400 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ICAM FUNDUS CAMERA OPTOVUE, INC. 510(k) NO: K122572(TRADITIONAL) ATTN: AZIMUN JAMAL PHONE NO : 510 623 8868 2800 Bayview Dr SE DECISION MADE: 11-JAN-13 FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRANSFORM OCCLUSION BALLOON CATHETER (COMPLIANT AND SUPER COMPLIANT STRYKER NEUROVASCULAR 510(k) NO: K122576(TRADITIONAL) ATTN: JAMES LEATHLEY PHONE NO : 510 413 2500 47900 BAYSIDE PARKWAY SE DECISION MADE: 11-JAN-13 FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANGIOSCULPT PTA SCORING BALLOON CATHETER ANGIOSCORE, INC. 510(k) NO: K122685(TRADITIONAL) ATTN: KIMBERLEY KLINE PHONE NO : 510 933 7989 5055 BRANDIN COURT SE DECISION MADE: 11-JAN-13 FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HD-IVUS ULTRASOUND IMAGING SYSTEM SILICON VALLY MEDICAL INSTRUMENTS,510(k) NO: K122878(SPECIAL) ATTN: RICHARD E ANDERSON PHONE NO : 510 897 4695 47697 WESTINGHOUSE SUITE 101 SE DECISION MADE: 11-JAN-13 FREMONT CA 94539 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIVIX-S WITH VXVUE VIEWORKS CO., LTD. 510(k) NO: K122866(TRADITIONAL) ATTN: PRISCILLA CHUNG PHONE NO : 714 869 3080 951 STARBUCK ST UNIT J SE DECISION MADE: 11-JAN-13 FULLERTON CA 92833 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SELECTRA 7F CATHETERS BIOTRONIK, INC. 510(k) NO: K123324(SPECIAL) ATTN: JON BRUMBAUGH PHONE NO : 888 345 0374 6024 JEAN ROAD SE DECISION MADE: 11-JAN-13 LAKE OSWEGO OR 97035 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 1.5T GEM RT OPEN ARRAY GE HEALTHCARE COILS (USA INSTRUMEN510(k) NO: K123327(TRADITIONAL) ATTN: ANDREW MENDEN PHONE NO : 262 521 6223 1515 DANNER DR SE DECISION MADE: 11-JAN-13 AURORA OH 44202 9273 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWEREASE SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K123270(TRADITIONAL) ATTN: JULIE BASSETT PHONE NO : 800 876 3133 1800 PYRAMID PLACE SE DECISION MADE: 11-JAN-13 Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QXMEDICAL ACCESS & SUPPORT CATHETER QXMEDICAL, LLC 510(k) NO: K123311(TRADITIONAL) ATTN: FERNANDO DI CAPRIO PHONE NO : 651 338 5774 1843 Buerkle Rd SE DECISION MADE: 14-JAN-13 White Bear Lake MN 55110 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL CENTERS FOR DISEASE CONTROL AND PR510(k) NO: K123905(SPECIAL) ATTN: HYE-JOO KIM, PHARM. D PHONE NO : 404 639 4643 1600 CLIFTON RD. NE (MS C-18) SE DECISION MADE: 14-JAN-13 ATLANTA GA 30333 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR ABBOTT LABORATORIES 510(k) NO: K123372(TRADITIONAL) ATTN: LINDA MORRIS PHONE NO : 972 518 6711 1921 HURD DR. SE DECISION MADE: 14-JAN-13 IRVING TX 75038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REMESENSE FOR SENSITIVE TEETH SYLPHAR N.V. 510(k) NO: K122708(TRADITIONAL) ATTN: ROGER GRAY PHONE NO : 390 657 82665 PIAZZA ALBANIA 10 SE DECISION MADE: 14-JAN-13 ROME, ITALY IT 00153 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM CONFORMIS, INC. 510(k) NO: K122870(TRADITIONAL) ATTN: AMITA S SHAH PHONE NO : 781 345 9164 11 NORTH AVENUE SE DECISION MADE: 14-JAN-13 BURLINGTON MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCULIF TL AND PL CAGE COALIGN INNOVATIONS, INC. 510(k) NO: K123752(TRADITIONAL) ATTN: JUSTIN EGGLETON PHONE NO : 202 552 5800 1331 H STREET NW 12TH FLOOR SE DECISION MADE: 14-JAN-13 WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FORA V10 BLOOD GLUCOSE MONITORING SYSTEM FORA CARE INC. 510(k) NO: K121706(TRADITIONAL) ATTN: PINJUNG CHEN PHONE NO : 886 266 258188 6F, NO. 127, WUGONG 2ND RD., WUGU SE DECISION MADE: 14-JAN-13 NEW TAIPEI CITY TW 24888 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING AND PRESSURE SYSTEM VOLCANO CORPORATION 510(k) NO: K123898(SPECIAL) ATTN: JWALA JAWHARKAR PHONE NO : 916 281 2925 2870 KILGORE RD. SE DECISION MADE: 14-JAN-13 RANCHO CORDOVA CA 95670 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING KCI USA, INC. (KINETIC CONCEPTS, I510(k) NO: K123878(SPECIAL) ATTN: SHANNON SCOTT PHONE NO : 210 515 4368 6203 FARINON DRIVE SE DECISION MADE: 15-JAN-13 SAN ANTONIO TX 78249 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MIRA LASERS MIRA LASERS LLC 510(k) NO: K123004(TRADITIONAL) ATTN: DIANA HONG PHONE NO : 862 122815 850 P.O. BOX 237-023 SE DECISION MADE: 15-JAN-13 SHANGHAI CH 200237 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ILAB ULTRASOUND IMAGING SYSTEM BOSTON SCIENTIFIC CORP. 510(k) NO: K123535(SPECIAL) ATTN: LORI R SMITH PHONE NO : 510 624 1698 47215 LAKEVIEW SE DECISION MADE: 15-JAN-13 FREMONT CA 94538 6515 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VASOPOUSE DEEP VEIN THROMBOSIS COMPRESSION DEVICE MODEL IPCS, MODEL SQS CAREMED SUPPLY, INC. 510(k) NO: K122873(SPECIAL) ATTN: MICHAEL LEE PHONE NO : 886 2 28096995 7F, NO.2, LANE 235, BAO CHIAO RD NSE DECISION MADE: 15-JAN-13 TAIPEI XEN DISTRICT CH 23145 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTEGRATED COLLIMATOR VERIFICATION AND INTERLOCK SYSTEM (ICVI) VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K123788(TRADITIONAL) ATTN: PETER J CORONADO PHONE NO : 650 424 6320 3100 HANSEN WAY SE DECISION MADE: 15-JAN-13 PALO ALTO CA 94304 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ERGO IMAGING SYSTEM DIGIRAD CORP. 510(k) NO: K123408(TRADITIONAL) ATTN: MATTHEW OLOW PHONE NO : 858 726 1309 13950 STOWE DRIVE SE DECISION MADE: 15-JAN-13 POWAY CA 92064 8803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OCS-B NIBEC COMPANY, LIMITED 510(k) NO: K113246(TRADITIONAL) ATTN: DANIEL NAM PHONE NO : 213 626 1544 4568 W. 1ST STREET SUITE 104 SE DECISION MADE: 16-JAN-13 LOS ANGELES CA 90004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNGO DYNAMICS SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K123922(TRADITIONAL) ATTN: YURI IKEDA PHONE NO : 734 205 2442 400 W. MORGAN ROAD SUITE 100 SE DECISION MADE: 16-JAN-13 ANN ARBOR MI 48108 9117 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PRO HMPV+ ASSAY GEN-PROBE PRODESSE, INC. 510(k) NO: K123838(SPECIAL) ATTN: KAREN HARRINGTON PHONE NO : 262 953 8415 20925 CROSSROADS CIRCLE SE DECISION MADE: 16-JAN-13 Waukesha WI 53186 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOVATION CROWN CUP LINERS; NEUTRAL, LIPPED, +5MM LATERALIZED, +5/10 DEGREE EXACTECH, INC. 510(k) NO: K121392(SPECIAL) ATTN: LINDY KNISELY PHONE NO : 352 377 1140 2320 N.W. 66TH CT. SE DECISION MADE: 16-JAN-13 GAINESVILLE FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WELLAHO PERSONALIZED OUTPATIENT MANAGEMENT SYSTEM SANITAS, INC. 510(k) NO: K123671(TRADITIONAL) ATTN: ALAN DONALD PHONE NO : 858 485 8584 11440 W. BERNARDO COURT, STE 300 SE DECISION MADE: 16-JAN-13 SAN DIEGO CA 92127 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DK-PTCA BALLOON CATHETER INTUIT MEDICAL, LLC 510(k) NO: K123264(TRADITIONAL) ATTN: JACK C GRIFFIS PHONE NO : 404 583 6889 6018 EAGLE'S REST TRAIL SE DECISION MADE: 16-JAN-13 SUGAR HILL GA 30518 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AURIGA QI STARMEDTEC GMBH 510(k) NO: K121570(TRADITIONAL) ATTN: GREGOR WEIDEMANN PHONE NO : 498 151 268610 KREUZSTRASSE 22 SE DECISION MADE: 16-JAN-13 STARNBERG GM 82319 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MERIT HYDROPHILIC GUIDE WIRE MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K123609(SPECIAL) ATTN: STEPHANIE ERSKINE PHONE NO : 801 208 4349 1111 South Velasco St SE DECISION MADE: 16-JAN-13 Angleton TX 77515 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SWISS LITHOBREAKER EMS ELECTRO MEDICAL SYSTEMS SA 510(k) NO: K123038(TRADITIONAL) ATTN: SUZANNE GOODMAN PHONE NO : 919 608 6082 225 TURNPIKE ROAD SE DECISION MADE: 16-JAN-13 SOUTHBOROUGH MA 01772 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROGASTRO SSCS ASSAY GEN-PROBE PRODESSE, INC. 510(k) NO: K123274(TRADITIONAL) ATTN: KAREN HARRINGTON PHONE NO : 262 953 8415 20925 CROSSROADS CIRCLE SE DECISION MADE: 16-JAN-13 Waukesha WI 53186 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONVENTUS ORTHOPAEDICS FRACTURE FIXATION SYSTEM CONVENTUS ORTHOPAEDICS 510(k) NO: K102689(TRADITIONAL) ATTN: HOLLACE S RHODES PHONE NO : 202 552 5800 1331 H STREET NW 12TH FLOOR SE DECISION MADE: 17-JAN-13 WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BRIVO MR355, OPTIMA MR360 GE HANGWEI MEDICAL SYSTEMS CO., LT510(k) NO: K123417(TRADITIONAL) ATTN: RUOQIAN LIU PHONE NO : 86 10 58068943 NO.2, YONG CHANG NORTH RD. BEIJINGSE DECISION MADE: 17-JAN-13 BEIJING CH 100176 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TEXTURED, NATURAL TO OFF-WHITE, LATEX, STERILE, POWDER FREE EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 UG/DM2 O CYPRESS MEDICAL PRODUCTS LLC 510(k) NO: K122788(TRADITIONAL) ATTN: ANTONIO GIACCIO PHONE NO : 815 385 0100 1202 SOUTH ROUTE 31 SE DECISION MADE: 17-JAN-13 MCHENRY IL 60050 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: AVANCE FOAM DRESSING KIT INCL. TRANSPARENT FILM, TRANSFER PAD (SMALL, MEDIUM, LARGE) AVANCE TRANSPARENT FILM AVANCE FOAM MOLNLYCKE HEALTH CARE 510(k) NO: K122132(TRADITIONAL) ATTN: ANGELA L BUNN PHONE NO : 678 250 7930 5550 PEACHTREE PARKWAY SUITE 500 SE DECISION MADE: 17-JAN-13 NORCROSS GA 30092 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZEPHYR 'X-SERIES" PATIENT TRANSFER SLED DIACOR, INC. 510(k) NO: K121929(TRADITIONAL) ATTN: KEVIN ANDERSON PHONE NO : 801 467 0050 2550 DECKER LAKE BLVD. SUITE 26 SE DECISION MADE: 17-JAN-13 West Valley City UT 84119 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MED-FIBERS SURGICAL LASER FIBER, MED-FIBERS ENDO-ENT LASER PROBES, MED-FIBERS END- AND ASPIRATING LASER PROBES, MED-FIBE MED-FIBERS, INC. 510(k) NO: K124003(TRADITIONAL) ATTN: ARMIN KAUS PHD PHONE NO : 480 516 8454 2675 E. BARTLETT PLACE SE DECISION MADE: 17-JAN-13 CHANDLER AZ 85249 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110 ICAD, INC. 510(k) NO: K122951(TRADITIONAL) ATTN: JOHN A DELUCIA PHONE NO : 603 882 5200 98 SPIT BROOK ROAD SUITE 100 SE DECISION MADE: 17-JAN-13 NASHUA NH 03062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRUX VENA CAVA FILTER SYSTEM CRUX BIOMEDICAL 510(k) NO: K122585(SPECIAL) ATTN: ELISA HEBB PHONE NO : 650 321 9903 1455 ADAMS DRIVE, #1170 SE DECISION MADE: 17-JAN-13 MENLO PARK CA 94025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HERO I DENTAL IMPLANT SYSTEM KJ MEDITECH CO., LTD 510(k) NO: K121098(TRADITIONAL) ATTN: PRISCILLA CHUNG PHONE NO : 714 869 3080 951 STARBUCK ST. UNIT J SE DECISION MADE: 17-JAN-13 FULLERTON CA 92833 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRETZELFLEX SURGICAL RETRACTOR MODEL SHR7301 SURGICAL INNOVATIONS PLC 510(k) NO: K123110(SPECIAL) ATTN: TRACEY FEARNLEY PHONE NO : 440 11 32307597 CLAYTON WOOD HOUSE, 6 CLAYTON WOODSE DECISION MADE: 17-JAN-13 LEEDS, WEST YORKSHIRE UK LS16 6510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT) FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K121421(SPECIAL) ATTN: COLLEEN DURRAN PHONE NO : 781 699 4480 920 WINTER STREET SE DECISION MADE: 17-JAN-13 WALTHAM MA 01854 1457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM BECTON DICKINSON INFUSION THERAPY 510(k) NO: K123734(TRADITIONAL) ATTN: KIMBERLY GEISLER PHONE NO : 801 565 2422 9450 S State St SE DECISION MADE: 17-JAN-13 SANDY UT 84070 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RESORB-X G KLS-MARTIN L.P. 510(k) NO: K121606(TRADITIONAL) ATTN: JENNIFER DAMATO PHONE NO : 904 641 7746 11201 SAINT JOHNS INDUSTRIAL PARKWSE DECISION MADE: 17-JAN-13 JACKSONVILLE FL 32246 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA FUJIREBIO DIAGNOSTICS, INC. 510(k) NO: K123612(TRADITIONAL) ATTN: KENT PRUETT PHONE NO : 830 372 1391 940 CROSSROADS BLVD. SE DECISION MADE: 17-JAN-13 SEGUIN TX 78155 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WARMAIR MODEL 135 HYPERTHERMIA SYSTEM INCLUDING FILTEREDFLO BLANKETS CINCINNATI SUB-ZERO PRODUCTS, INC 510(k) NO: K123946(SPECIAL) ATTN: STEVEN J BERKE PHONE NO : 513 772 8810 12011 MOSTELLER ROAD SE DECISION MADE: 17-JAN-13 CINCINNATI OH 45241 1528 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES (BLACK, WHITE, GREEN) HONGYE PLASTIC PRODUCTS CO., LTD. 510(k) NO: K122408(TRADITIONAL) ATTN: KATHY LIU PHONE NO : 909 590 1611 3973 SCHAFER AVE. SE DECISION MADE: 17-JAN-13 CHINO CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADS ST. JUDE MEDICAL NEUROMODULATION 510(k) NO: K123299(TRADITIONAL) ATTN: TERRINA WILDER, RAC PHONE NO : 972 309 8115 6901 PRESTON RD. SE DECISION MADE: 18-JAN-13 PLANO TX 75024 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INNESIS PEEK CAGE BK MEDITECH CO., LTD. 510(k) NO: K120464(TRADITIONAL) ATTN: SHIN KUK YOO PHONE NO : 714 313 7442 8 EAST BROADWAY, STE 611 SE DECISION MADE: 18-JAN-13 SALT LAKE CITY UT 84111 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNGO.VIA SIEMENS AG, MEDICAL SOLUTIONS 510(k) NO: K123920(TRADITIONAL) ATTN: SABINE SCHROEDEL PHONE NO : 499 131848 285 HENKESTRASSE 127 SE DECISION MADE: 18-JAN-13 ERLANGEN GM 91052 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: BD PEN NEEDLE BECTON DICKINSON & CO. 510(k) NO: K123300(SPECIAL) ATTN: PASQUALE AMATO PHONE NO : 201 847 4513 1 BECTON DR. MC 372 SE DECISION MADE: 18-JAN-13 FRANKLIN LAKES NJ 07417 1880 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VASCULAR POSITIONING SYSTEM (VPS) G4 CONSOLE VASONOVA INC. 510(k) NO: K123813(SPECIAL) ATTN: CHRISTINE FORD PHONE NO : 610 378 0131 155 JEFFERSON DRIVE SUITE 100 SE DECISION MADE: 18-JAN-13 MENLO PARK CA 94025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GENESIS DORNIER MEDTECH AMERICA, INC. 510(k) NO: K122768(TRADITIONAL) ATTN: JOHN J SMITH PHONE NO : 202 637 3638 555 THIRTEENTH STREET, NW SE DECISION MADE: 18-JAN-13 WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDIAC VX GE MEDICAL SYSTEMS, LLC 510(k) NO: K121762(TRADITIONAL) ATTN: MICHELLE HUETTNER PHONE NO : 262 521 6102 3200 N. GRANDVIEW BLVD. SE DECISION MADE: 18-JAN-13 WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE BLUE NITRILE EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGS TEKMEDIC (M) SDN BHD 510(k) NO: K121592(TRADITIONAL) ATTN: PATRICK LEONG PHONE NO : 606 351095 9 PLOT 4, TANJUNG KLING INDUSTRIAL ASE DECISION MADE: 18-JAN-13 JETTY, TANJUNG KLING, MALACCA M510(k) STATEMENT DEVICE: CALIBER SPACERS GLOBUS MEDICAL INC. 510(k) NO: K123231(TRADITIONAL) ATTN: CHRISTINA KICHULA PHONE NO : 610 930 1800 2560 GENERAL ARMISTEAD AVE. SE DECISION MADE: 18-JAN-13 AUDUBON PA 19403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEUROPACE BURR HOLE COVER MODEL 8110 NEUROPACE INC 510(k) NO: K123163(TRADITIONAL) ATTN: ISABELLA ABATI PHONE NO : 650 237 2777 455 N. BERNARDO AVE SE DECISION MADE: 18-JAN-13 MOUNTAIN VIEW CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IVUE WITH NORMATIVE DATABASE OPTOVUE, INC. 510(k) NO: K121739(TRADITIONAL) ATTN: AZIMUN JAMAL PHONE NO : 510 623 8868 45531 Northport Loop W SE DECISION MADE: 18-JAN-13 FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GEMINUS FOSSA SPECIFIC PLATE SYSTEM SKELETAL DYNAMICS, LLC 510(k) NO: K122310(TRADITIONAL) ATTN: ANA M ESCAGEDO PHONE NO : 305 596 7585 8905 SW 87 AVENUE, SUITE 201 SE DECISION MADE: 18-JAN-13 MIAMI FL 33176 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XGEO GC80 SAMSUNG ELECTRONICS CO., LTD. 510(k) NO: K123098(TRADITIONAL) ATTN: CHARLIE MACK PHONE NO : 541 376 5063 77325 JOYCE WAY SE DECISION MADE: 18-JAN-13 ECHO OR 97826 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES, BLUE AND BLACK NITRILIST GLOVES MANUFACTURING SDN510(k) NO: K123328(TRADITIONAL) ATTN: LAU SIONG HUT PHONE NO : 606 481 1876 PT 197, KAWASAN PERINDUSTRIAN DIOHSE DECISION MADE: 18-JAN-13 KUALA PILAH MY 72000 510(k) STATEMENT DEVICE: PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM HITACHI ALOKA MEDICAL, LTD. 510(k) NO: K123828(TRADITIONAL) ATTN: ANGELA VAN ARSDALE PHONE NO : 203 269 5088 10 FAIRFIELD BLVD. SE DECISION MADE: 18-JAN-13 WALLINGFORD CT 06492 5903 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND CARMEDA BIOACTIVE SURFACE MEDTRONIC INC. 510(k) NO: K123314(TRADITIONAL) ATTN: MARY E DONLIN PHONE NO : 763 526 9172 7611 NORTHLAND DRIVE SE DECISION MADE: 22-JAN-13 MINNEAPOLIS MN 55428 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TBA MIGADA PLANT 510(k) NO: K121269(TRADITIONAL) ATTN: YOSSI SHACHAR PHONE NO : 972 469 08800 NORTH INDUSTRIAL ZONE SE DECISION MADE: 22-JAN-13 KIRYAT SHMONA IS 10258 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTENSE PULSED LIGHT (IPL) SYSTEMS BEIJING KES BIOLOGY TECHNOLOGY CO.510(k) NO: K122995(TRADITIONAL) ATTN: DIANA HONG PHONE NO : 862 122815 850 P.O. BOX 237-023 SE DECISION MADE: 22-JAN-13 SHANGHAI CH 200237 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CATHETER CONNECTIONS' DARK BLUE DUALCAP FOR MALE LUERS CATHETER CONNECTIONS, INC. 510(k) NO: K123967(SPECIAL) ATTN: DONALD D SOLOMON PHONE NO : 801 209 1269 615 Arapeen Dr Ste 302A SE DECISION MADE: 22-JAN-13 Salt Lake City UT 84108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERMASORB DISPOSABLE FIXATION DEVICE C.R. BARD INC 510(k) NO: K123718(SPECIAL) ATTN: RADHIKA PONDICHERRY PHONE NO : 401 825 8464 100 CROSSINGS BOULEVARD SE DECISION MADE: 22-JAN-13 WARWICK RI 02886 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNAPSE 3D COLON ANALYSIS FUJIFILM MEDICAL SYSTEMS U.S.A., I510(k) NO: K123566(TRADITIONAL) ATTN: JYH-SHYAN LIN PHONE NO : 301 301 1092 419 WEST AVE. SE DECISION MADE: 22-JAN-13 STAMFORD CT 06902 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNGO.VIA MI WORKFLOWS SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K123577(SPECIAL) ATTN: ALAINE MEDIO, RAC PHONE NO : 865 218 2703 810 INNOVATION DR. SE DECISION MADE: 22-JAN-13 KNOXVILLE TN 37934 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BACT/ALERT FA PLUS CULTURE BOTTLE BIOMERIEUX, INC. 510(k) NO: K121461(TRADITIONAL) ATTN: JOCELYN JENNINGS PHONE NO : 919 620 2894 100 RODOLPHE ST SE DECISION MADE: 22-JAN-13 DURHAM NC 27712 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEPAIRX VENTILATING AIR PURIFIER AIR INNOVATIONS, INC. 510(k) NO: K112728(TRADITIONAL) ATTN: LAWRENCE WETZEL PHONE NO : 315 452 7400 7000 PERFORANCE DRIVE SE DECISION MADE: 23-JAN-13 NORTH SYRACUSE NY 13212 510(k) STATEMENT DEVICE: FINESSE 3RD GENERATION (MODELS FINESSE+ AND FINESSEII+) UTAH MEDICAL PRODUCTS, INC. 510(k) NO: K123310(TRADITIONAL) ATTN: BEN SHIRLEY PHONE NO : 800 533 4984 7043 South 300 West SE DECISION MADE: 23-JAN-13 Midvale UT 84047 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: FOOTPRINT ULTRA PK4.5MM AND 5.5MM SUTURE ANCHOR, SL SMITH & NEPHEW, INC. 510(k) NO: K123579(SPECIAL) ATTN: CATHERINE KILSHAW PHONE NO : 508 337 4104 150 MINUTEMAN ROAD SE DECISION MADE: 23-JAN-13 ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENVITEC MYSIGN O OXYGEN MEASURING DEVICE ENVITEC-WISMAR GMBH 510(k) NO: K122290(TRADITIONAL) ATTN: STEPHEN GORSKI PHONE NO : 262 594 2114 S65 W35739 PIPER ROAD SE DECISION MADE: 23-JAN-13 EAGLE WI 53119 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MARKIT TISSUE MARKER-1ML MARKIT TISSUE MARKER-3ML MARKIT TISSUE MARKER-10ML AUGMENIX , INC. 510(k) NO: K121964(TRADITIONAL) ATTN: ERIC ANKERUD PHONE NO : 781 902 1613 204 SECOND AVENUE LOWER LEVEL SE DECISION MADE: 23-JAN-13 WALTHAM MA 02451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSSEOSPEED ANGLED ABUTMENT EV ASTRA TECH AB 510(k) NO: K121810(TRADITIONAL) ATTN: LINDA K SCHULZ PHONE NO : 858 792 1235 11234 EL CAMINO REAL, SUITE 200 SE DECISION MADE: 23-JAN-13 SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TURON GLENOID PEGGED, E+, TURON KEELED GLENOID, E+ ENCORE MEDICAL, L.P. 510(k) NO: K123982(SPECIAL) ATTN: MICHAELA NORRIS PHONE NO : 512 834 6291 9800 METRIC BLVD. SE DECISION MADE: 23-JAN-13 AUSTIN TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCULIF TL-PEEK CAGE COALIGN INNOVATIONS, INC. 510(k) NO: K123281(TRADITIONAL) ATTN: JUSTIN EGGLETON PHONE NO : 202 552 5800 31 H STREET NW 12TH FLOOR SE DECISION MADE: 23-JAN-13 WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GAMMA3 AND T2 RECON TARGETING DEVICES STRYKER TRAUMA AG 510(k) NO: K123401(TRADITIONAL) ATTN: ESTELA CELI PHONE NO : 201 831 6461 325 CORPORATE DRIVE SE DECISION MADE: 23-JAN-13 MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DURABLUE STERILIZATION WRAP CARDINAL HEALTH 200, LLC 510(k) NO: K123857(TRADITIONAL) ATTN: LAVENIA FORD PHONE NO : 847 887 3323 1430 WAUKEGAN ROAD SE DECISION MADE: 23-JAN-13 WAUKEGAN IL 60085 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET DIAZYME LABORATORIES 510(k) NO: K112120(TRADITIONAL) ATTN: ABHIJIT DATTA PHONE NO : 858 455 4762 12889 GREGG COURT SE DECISION MADE: 24-JAN-13 POWAY CA 92064 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED STEERABLE INTRODUCER STRYKER SUSTAINABILITY SOLUTIONS, 510(k) NO: K123334(TRADITIONAL) ATTN: AMANDA BABCOCK PHONE NO : 888 888 3433 10232 S. 51st St. SE DECISION MADE: 24-JAN-13 Phoenix AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SR NEXCO PASTE LAYERING MATERIALS, SR NEXCO OPAQUER, SR NEXCO LINER-SR NEXCO CONNECT, SR NEXCO STAINS, SR NEXCO RETENTIO IVOCLAR VIVADENT AG 510(k) NO: K123304(ABBREVIATED) ATTN: DONNA M HARTNETT PHONE NO : 716 691 2260 175 PINEVIEW DR. SE DECISION MADE: 24-JAN-13 AMHERST NY 14228 510(k) STATEMENT DEVICE: VITRA MULTISPOT QUANTEL MEDICAL 510(k) NO: K122251(TRADITIONAL) ATTN: MAUREEN O'CONNELL PHONE NO : 978 207 1245 5 TIMBER LANE SE DECISION MADE: 24-JAN-13 NORTH READING MA 01864 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUREFLEX STEERABLE GUIDING SHEATH KIT BAYLIS MEDICAL CO., INC. 510(k) NO: K122926(TRADITIONAL) ATTN: MEGHAL KHAKHAR PHONE NO : 905 602487 5 2645 MATHESON BLVD. E SE DECISION MADE: 24-JAN-13 MISSISSAUGA, ONTARIO CA L4W 5S4510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POINT 500 HD POINT500C HD POINTNIX CO., LTD 510(k) NO: K121800(TRADITIONAL) ATTN: JIGAR SHAH PHONE NO : 516 482 9001 55 NORTHERN BLVD SE DECISION MADE: 24-JAN-13 GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VASHE SKIN AND WOUND HYDROGEL PURICORE, INC. 510(k) NO: K123071(TRADITIONAL) ATTN: ART MORSE PHONE NO : 484 321 2728 508 LAPP ROAD SE DECISION MADE: 24-JAN-13 MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARISTA DIRECT GAS-ASSISTED APPLICATION SYSTEM MEDAFOR, INC. 510(k) NO: K123325(TRADITIONAL) ATTN: MELISSA YOUNG PHONE NO : 763 231 8204 2700 FREEWAY BLVD SUITE 800 SE DECISION MADE: 24-JAN-13 MINNEAPOLIS MN 55430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BACT/ALERT FN PLUS CULTURE BOTTLE BIOMERIEUX, INC. 510(k) NO: K121455(TRADITIONAL) ATTN: PATRICIA MURPHY PHONE NO : 919 620 2270 100 RODOLPHE ST SE DECISION MADE: 25-JAN-13 DURHAM NC 27712 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENSEAL G2 ARTICULATING TISSUE SEALERS, STRAIGHT JAW, ENSEAL G2 ARTICULATING TISSUE SEALERS, CURVED JAW ETHICON ENDO-SURGERY, LLC 510(k) NO: K122797(TRADITIONAL) ATTN: EMILY KRUETZKAMP PHONE NO : 513 337 1546 4545 CREEK ROAD SE DECISION MADE: 25-JAN-13 CINCINNATI OH 45242 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS), AND TRUFILL DCS ORBIT DETACHABLE COIL SYSEM CODMAN & SHURTLEFF, INC. 510(k) NO: K123560(SPECIAL) ATTN: RICHARD KIMURA PHONE NO : 408 433 1419 325 PARAMOUNT DR. SE DECISION MADE: 25-JAN-13 RAYNHAM MA 02767 0350 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASA LASER SH1 EL.EN. ELECTRONIC ENGINEERING SPA 510(k) NO: K122125(TRADITIONAL) ATTN: PAOLO PERUZZI PHONE NO : 390 558 826807 17 VIA BALDANZESE SE DECISION MADE: 25-JAN-13 CALENZANO IT 50041 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BACT/ALERT PF PLUS CULTURE BOTTLE BIOMERIEUX, INC. 510(k) NO: K121446(TRADITIONAL) ATTN: ELIZABETH LANDON PHONE NO : 919 620 2329 100 RODOLPHE ST SE DECISION MADE: 25-JAN-13 DURHAM NC 27712 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLUCOSE METER-CHECK SOLUTION FOR BAYER BIONOSTICS, INC. 510(k) NO: K123966(TRADITIONAL) ATTN: RANDY BYRD PHONE NO : 978 862 1830 7 JACKSON RD. SE DECISION MADE: 25-JAN-13 Devens MA 01434 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWER LED 175 KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K123956(TRADITIONAL) ATTN: SHIVEN GANDHI PHONE NO : 424 218 8322 2151 E. GRAND AVE. SE DECISION MADE: 25-JAN-13 EL SEGUNDO CA 90245 5017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ESA615 FLUKE BIOMEDICAL 510(k) NO: K121860(TRADITIONAL) ATTN: JOHN NELSON PHONE NO : 440 498 2579 6045 COCHRAN RD. SE DECISION MADE: 25-JAN-13 SOLON OH 44139 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZERONA 2.0 LASER ERCHONIA CORPORATION 510(k) NO: K123237(TRADITIONAL) ATTN: KEVIN WALLS PHONE NO : 720 962 5412 33 GOLDEN EAGLE LANE SE DECISION MADE: 25-JAN-13 LITTLETON CO 80127 510(k) STATEMENT DEVICE: 2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035 SPECTRANETICS CORP. 510(k) NO: K123632(TRADITIONAL) ATTN: CHRISTINE GODLESKI PHONE NO : 719 447 2414 9665 FEDERAL DRIVE SE DECISION MADE: 25-JAN-13 COLORADO SPRINGS CO 80921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDYSSEY CANNULATED PEDICLE SCREW MEDYSSEY CO., LTD. 510(k) NO: K121670(TRADITIONAL) ATTN: MICHAEL KVITNITSKY PHONE NO : 847 982 0100 8001 N. LINCOLN AVE SUITE 401 SE DECISION MADE: 25-JAN-13 SKOKIE IL 60077 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIAISON TESTOSTERONE; LIAISON TESTOSTERONE CONTROL SET DIASORIN, INC. 510(k) NO: K122793(TRADITIONAL) ATTN: JOHN ESKDALE PHONE NO : 651 439 9710 1951 NORTHWESTERN AVE. SE DECISION MADE: 25-JAN-13 STILLWATER MN 55082 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LANTOS 3D EAR SCANNER LANTOS TECHNOLOGIES 510(k) NO: K121326(TRADITIONAL) ATTN: JOHN GREENBAUM PHONE NO : 954 610 0178 20310 SW 48TH ST SE DECISION MADE: 25-JAN-13 SOUTHWEST RANCHES FL 33332 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED VESSEL SEALER STERILMED, INC. 510(k) NO: K123096(TRADITIONAL) ATTN: JASON SKRAMSTED PHONE NO : 763 488 3483 11400 73RD AVE. NORTH, No. 100 SE DECISION MADE: 25-JAN-13 MAPLE GROVE MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DECLIPSESPECT VIEWER SURGICEYE GMBH 510(k) NO: K123917(SPECIAL) ATTN: MORITZ HOYER PHONE NO : 49 89 549989024 Friedenstr. 18a SE DECISION MADE: 25-JAN-13 Munich DE 81671 510(k) STATEMENT DEVICE: SYSTEM 83 PLUS CUSTOM ULTRASONICS 510(k) NO: K122172(SPECIAL) ATTN: FRANK J WEBER PHONE NO : 215 364 1477 144 RAILROAD DR. SE DECISION MADE: 25-JAN-13 IVYLAND PA 18974 510(k) STATEMENT DEVICE: ESWALLOW USA ELECTRODE,ESWALLOW USA LEADWIRE ESWALLOW USA 510(k) NO: K113375(TRADITIONAL) ATTN: WILLIAM INGRAM PHONE NO : 256 571 0443 3477 CREEK CIRCLE SE DECISION MADE: 25-JAN-13 GUNTERSVILLE AL 35976 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 GE GE200 BLOOD GLUCOSE MONITORING SYSTEM RIGHTEST BLOOD GLUCOSE MONITORIN BIONIME CORPORATION 510(k) NO: K123008(SPECIAL) ATTN: JIGAR SHAH PHONE NO : 516 482 9001 55 NORTHERN BLVD. SUITE 200 SE DECISION MADE: 25-JAN-13 GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMITH & NEPHEW, INC SCREW AND PLATE SYSTEM INSTRUMENTATION SMITH & NEPHEW, INC. 510(k) NO: K123055(TRADITIONAL) ATTN: BRADLEY HEIL PHONE NO : 901 399 6339 7135 GOODLETT FARMS PARKWAY SE DECISION MADE: 25-JAN-13 CORDOVA TN 38016 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MULTIPLE NAME ASSURGUARD SDN. BHD. 510(k) NO: K123760(TRADITIONAL) ATTN: LIM HUI GUAN PHONE NO : 603 329710 20 82F, JALAN PULASAN KLANG SE DECISION MADE: 28-JAN-13 SELANGOR DARUL EHSAN MY 41000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHOCON ABSORBABLE HEMOSTATIC BONE PUTTY ORTHOCON, INC. 510(k) NO: K122156(TRADITIONAL) ATTN: RICHARD KRONENTHAL PHONE NO : 914 357 2600 1 Bridge St Ste 121 SE DECISION MADE: 28-JAN-13 Irvington NY 10533 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AXERA 2 ACCESS SYSTEM MODEL AXE200 ARSTASIS, INC. 510(k) NO: K123135(TRADITIONAL) ATTN: DEBRA COGAN PHONE NO : 650 261 8073 740 BAY RD SE DECISION MADE: 28-JAN-13 REDWOOD CITY CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PACIFIC PLUS MEDTRONIC VASCULAR 510(k) NO: K123358(TRADITIONAL) ATTN: DIANA JOHNSON PHONE NO : 707 591 2656 3576 UNOCAL PLACE SE DECISION MADE: 29-JAN-13 SANTA ROSA CA 95403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOGRAPH MCT FAMILY SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K123737(SPECIAL) ATTN: ALAINE MEIDO, RAC PHONE NO : 865 218 2703 810 INNOVATION DR. SE DECISION MADE: 29-JAN-13 KNOXVILLE TN 37934 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILY ABBOTT VASCULAR INC. 510(k) NO: K123067(TRADITIONAL) ATTN: SEAN MULLIN PHONE NO : 951 914 3031 P.O. BOX 9018 SE DECISION MADE: 29-JAN-13 TEMECULA CA 92591 9018 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VARILIFT -C WENZEL SPINE 510(k) NO: K120603(TRADITIONAL) ATTN: SOURABH MISHRA PHONE NO : 512 501 4017 206 Wild Basin Road Building A, SuSE DECISION MADE: 29-JAN-13 Austin TX 78746 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: A-SCAN PLUS CONNECT ACCUTOME, INC. 510(k) NO: K123349(SPECIAL) ATTN: ADAM PICKHOLTZ PHONE NO : 610 889 0200 3222 Phoenixville Pike SE DECISION MADE: 29-JAN-13 MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMAGEQUBE INTUITIVE IMAGING INFORMATICS, LLC510(k) NO: K124048(TRADITIONAL) ATTN: CINDY SIMONI PHONE NO : 818 347 8919 30 HACKAMORE LN, SUITE 6 SE DECISION MADE: 29-JAN-13 BELL CANYON CA 91307 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: HEARTSPAN STEERABLE INTRODUCER KIT THOMAS MEDICAL PRODUCTS, INC. 510(k) NO: K122431(TRADITIONAL) ATTN: TIM STOUDT PHONE NO : 610 651 5000 65 GREAT VALLEY PKWY. SE DECISION MADE: 29-JAN-13 MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONTRAST ENHANCED DIGITAL MAMMOGRAPHY HOLOGIC, INC. 510(k) NO: K123873(TRADITIONAL) ATTN: DEBORAH THOMAS PHONE NO : 781 999 7558 35 CROSBY DR. SE DECISION MADE: 29-JAN-13 BEDFORD MA 01730 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INION CPS ORBITAL PLATES INION OY 510(k) NO: K122890(TRADITIONAL) ATTN: KATI MARTTINEN PHONE NO : 358 10 8306611 LAAKARINKATU 2 SE DECISION MADE: 29-JAN-13 TAMPERE FI 33520 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRACTUS TISSUEMAPPER REVIEWER APPLICATION TRACTUS CORPORATION 510(k) NO: K123901(TRADITIONAL) ATTN: ERIC EGGERS PHONE NO : 981 EL CAJON DR. SUITE 100 SE DECISION MADE: 29-JAN-13 DANVILLE CA 94526 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: IMMUNOCAP ALLERGEN K82 THERMO FISHER SCIENTIFIC 510(k) NO: K121463(TRADITIONAL) ATTN: MARTIN MANN PHONE NO : 269 492 1957 4169 COMMERCIAL AVENUE SE DECISION MADE: 29-JAN-13 PORTAGE MI 49002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE ECHOPAC GE VINGMED ULTRASOUND AS 510(k) NO: K123894(TRADITIONAL) ATTN: BRYAN BEHN PHONE NO : 414 721 4214 9900 W INNOVATION DR., RP-2138 SE DECISION MADE: 29-JAN-13 WAUWATOSA WI 53226 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROCEDURE REHEARSAL STUDIO SIMBIONIX LTD. 510(k) NO: K123269(SPECIAL) ATTN: SHOSHANA FRIEDMAN PHONE NO : 704 899 0092 1914 J.N. PEASE PL. SE DECISION MADE: 29-JAN-13 CHARLOTTE NC 28262 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIGASURE IMPACT CURVED, LARGE JAW, OPEN SEALER / DIVIDER COVIDIEN, FORMERLY VALLEYLAB, A DI510(k) NO: K123444(TRADITIONAL) ATTN: DAWN TINDALL PHONE NO : 303 581 7034 5920 Longbow Dr SE DECISION MADE: 30-JAN-13 BOULDER CO 80301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GC AADVA ABUTMENT- ZIRCONIUM-BO AC BH SV GC AMERICA, INC. 510(k) NO: K113816(TRADITIONAL) ATTN: CARL H JENKINS PHONE NO : 847 234 7500 10 E. SCRANTON AVENUE SUITE 201 SE DECISION MADE: 30-JAN-13 LAKE BLUFF IL 60044 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL FLAT PANEL X-RAY DETECTOR/1417PGA RAYENCE CO., LTD 510(k) NO: K122928(TRADITIONAL) ATTN: DAVE KIM PHONE NO : 713 467 2607 12946 KIMBERLEY LN SE DECISION MADE: 30-JAN-13 HOUSTON TX 77079 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: T3 DENTAL IMPLANT BIOMET 3I 510(k) NO: K122300(TRADITIONAL) ATTN: TAMARA WEST PHONE NO : 561 776 3831 4555 RIVERSIDE DR. SE DECISION MADE: 30-JAN-13 Palm Bch Gdns FL 33410 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FASTECT II PPX DRUG SCREEN DIPSTICK, FASTECT II DRUG SCREEN DIPSTICK, QUICKTOX DRUG SCREEN DIPCARD BRANAN MEDICAL CORP. 510(k) NO: K122752(TRADITIONAL) ATTN: OLIVIA CHAN PHONE NO : 949 598 7166 140 Technology Dr Ste 400 SE DECISION MADE: 30-JAN-13 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ILUMIEN OPTIS LIGHTLAB IMAGING, INC. 510(k) NO: K123369(TRADITIONAL) ATTN: JEFFREY ROBERTS PHONE NO : 978 577 3451 4 ROBBINS ROAD SE DECISION MADE: 30-JAN-13 WESTFORD MA 01886 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MINI TREK RX CORONARY DILATATION CATHETER (INCLUDING 1.20 MM SIZE), MINI TREK OTW CORONARY DILATATION CATHETER (INCLUDIN ABBOTT VASCULAR 510(k) NO: K123279(TRADITIONAL) ATTN: SUZANNE REDMAN PHONE NO : 951 691 3243 26531 YNEZ ROAD P.O. BOX 9018 SE DECISION MADE: 30-JAN-13 TEMECULA CA 92589 9018 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEARPATH DS-120(R) LENS FLUORESCENCE BIOMICROSCOPE FREEDOM MEDITECH, INC. 510(k) NO: K112880(TRADITIONAL) ATTN: CRAIG H MISRACH PHONE NO : 619 846 6666 10455 PACIFIC CENTER COURT SE DECISION MADE: 31-JAN-13 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRASONIC SCALER NAKANISHI, INC. 510(k) NO: K113530(TRADITIONAL) ATTN: DIANE RUTHERFORD PHONE NO : 972 480 9554 1201 RICHARDSON DRIVE SUITE 280 SE DECISION MADE: 31-JAN-13 RICHARDSON TX 75080 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PALINDROME PRECISION H CHRONIC CATHETER, PALINDROME PRECISION SI CHRONIC CATHETER, PALINDROME PRECISION HSI CHRONIC CATH COVIDIEN 510(k) NO: K123196(TRADITIONAL) ATTN: JENNIFER SULLIVAN PHONE NO : 508 452 1659 15 HAMPSHIRE STREET SE DECISION MADE: 31-JAN-13 MANSFIELD MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE NITRILE EXAMINATION GLOVES (COOL BLUE) CARDINAL HEALTH, INC. 510(k) NO: K122696(TRADITIONAL) ATTN: TATYANA BOGDAN PHONE NO : 847 887 2325 1430 WAUKEGAN ROAD SE DECISION MADE: 31-JAN-13 MCGAW PARK IL 60085 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: LIQUICHEK SPINAL FLUID CONTROL LEVEL 1, LIQUICHEK SPINAL FLUID CONTROL LEVEL 2, LIQUICHEK SPINAL FLUID CONTROL MINIPAK BIO-RAD LABORATORIES 510(k) NO: K123775(TRADITIONAL) ATTN: SUZANNE PARSONS PHONE NO : 949 598 1467 9500 JERONIMO RD. SE DECISION MADE: 31-JAN-13 IRVINE CA 92618 2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DURETTE OCULAR IMPLANT OCULO-PLASTIK, INC. 510(k) NO: K123764(TRADITIONAL) ATTN: SYLVAIN DESROSIERS PHONE NO : 514 381 3292 200, RUE SAUVE OUEST SE DECISION MADE: 31-JAN-13 MONTREAL, QC CA H3L 1Y9 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MULTILINK AUTOMIX IVOCLAR VIVADENT AG 510(k) NO: K123397(TRADITIONAL) ATTN: SANDRA CAKEBREAD PHONE NO : 423 235 3535 BENDERERSTRASSE 2 SE DECISION MADE: 31-JAN-13 SCHAAN LS FL-9494 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAGNIFUSE BONE GRAFT (CLEARED AS GRAFTON II EDBM) MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K123691(TRADITIONAL) ATTN: MURIEL ASHIE PHONE NO : 901 396 3133 1800 PYRAMID PLACE SE DECISION MADE: 31-JAN-13 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: X4 SYSTEM ADVANCED BRAIN MONITORING INC. 510(k) NO: K130013(SPECIAL) ATTN: ADRIENNE LENZ PHONE NO : 262 290 0023 W324 S3649 COUNTY ROAD E SE DECISION MADE: 31-JAN-13 DOUSMAN WI 53118 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE ADVANCE CATHETER FOR HSG AND SIS CATHETER RESEARCH, INC. 510(k) NO: K123258(SPECIAL) ATTN: BABACAR DIOUF PHONE NO : 317 872 0074 5610 W 82nd St SE DECISION MADE: 31-JAN-13 INDIANAPOLIS IN 46278 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: V8 TRANSLUMINAL BAV CATHETER INTERVALVE, INC 510(k) NO: K123111(TRADITIONAL) ATTN: JULIE BODMER PHONE NO : 612 910 3412 84801 73RD AVENUE NORTH, SUITE 63 SE DECISION MADE: 31-JAN-13 MINNEAPOLIS MN 55428 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) WEALTH ON (JIANGSU) CO., LTD 510(k) NO: K122396(TRADITIONAL) ATTN: CHARLES SHEN PHONE NO : 608 217 9358 5 CAREY ST SE DECISION MADE: 31-JAN-13 PENNINGTON NJ 08534 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GEMINI STERILZATION WRAP MEDLINE INDUSTRIES, INC. 510(k) NO: K113353(TRADITIONAL) ATTN: MATT CLAUSEN PHONE NO : 847 643 4785 ONE MEDLINE PLACE SE DECISION MADE: 31-JAN-13 MUNDELEIN IL 60060 510(k) STATEMENT TOTAL 510(k)s THIS PERIOD 224 TOTAL WITH SUMMARIES 210 TOTAL WITH STATEMENTS 14
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