Medical Devices
-
August 2012 510(k) Clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD August 2012 DEVICE: ORION MICRO CATHETER MICRO THERAPEUTICS, INC. 510(k) NO: K113289(TRADITIONAL) ATTN: ANALIA NIETO PHONE NO : 949 680 1201 9775 TOLEDO WAY SE DECISION MADE: 01-AUG-12 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CELOX GAUZE PRO MEDTRADE PRODUCTS LTD. 510(k) NO: K113560(TRADITIONAL) ATTN: CLAIRE RYAN PHONE NO : 440 127 0500019 ELECTRA HOUSE CREWE BUSINESS PARK SE DECISION MADE: 01-AUG-12 CHESHIRE UK CW1 6GL 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOLAR GI MEDICAL MEASUREMENT SYSTEMS,B.V. 510(k) NO: K121014(TRADITIONAL) ATTN: K. OGINK SOMHORST PHONE NO : 315 348 03739 COLOSSEUM 25 SE DECISION MADE: 01-AUG-12 ENSCHEDE NL 7521 PV 510(k) STATEMENT DEVICE: WONDFO AMPHETAMINE URINE TEST WONDFO BARBITURATES URINE TEST WONDFO BENZODIAZEPINES URINE TEST GUANGZHOU WONDFO BIOTECH CO., LTD.510(k) NO: K121987(TRADITIONAL) ATTN: JOE SHIA PHONE NO : 240 505 7880 504 EAST DIAMOND AVE. SE DECISION MADE: 01-AUG-12 SUITE F GAITHERSBURG MD 20877 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDILAS H RFID LASER FIBER DORNIER MEDTECH AMERICA, INC. 510(k) NO: K121938(SPECIAL) ATTN: JOHN HOFFER PHONE NO : 770 514 6163 1155 ROBERTS BLVD. SE DECISION MADE: 01-AUG-12 KENNESAW GA 30144 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISITAL BLOOD PRESSURE MONITOR NIHON SEIMITSU SOKKI CO., LTD. 510(k) NO: K112620(TRADITIONAL) ATTN: KOJI KUBO PHONE NO : 813 598 16880 TOKYO OFFICE 2F, 6-5-3 KOMAGOME SE DECISION MADE: 02-AUG-12 BUNKYO-KU, TOKYO JA 113-0021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROLIFE WRIST WATCH BLOOD PREEURE MONITOR, BP3MO1-3P MICROLIFE INTELLECTUAL PROPERTY GM510(k) NO: K120430(SPECIAL) ATTN: SUSAN GOLDSTEIN-FALK PHONE NO : 949 706 7456 MDI CONSULTANTS, INC. 55 NORTHERN SE DECISION MADE: 02-AUG-12 GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOFTSEAL-C CHITOGEN, INC. 510(k) NO: K112864(TRADITIONAL) ATTN: JAMES F DRAKE PHONE NO : 952 835 5707 7255 OHMS LANE SE DECISION MADE: 02-AUG-12 MINNEAPOLIS MN 55439 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABACUS 3CP DIATRON US INC 510(k) NO: K111534(TRADITIONAL) ATTN: MICHAEL SWITZER PHONE NO : 954 790 9550 14026 W. 107TH STREET SE DECISION MADE: 02-AUG-12 LENEXA KS 66215 2005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELI 280 ELECTROCARDIOGRAPH MORTARA INSTRUMENT, INC. 510(k) NO: K122073(SPECIAL) ATTN: AMY YANG PHONE NO : 414 354 1600 7865 NORTH 86TH ST. SE DECISION MADE: 02-AUG-12 MILWAUKEE WI 53224 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE PULSION MEDICAL SYSTEMS SE 510(k) NO: K122121(SPECIAL) ATTN: JAMIE SULLEY PHONE NO : 919 426 4023 1511 ESSEX RD SE DECISION MADE: 02-AUG-12 WESTBROOK CT 06498 510(k) STATEMENT DEVICE: SONOTOUCH SERIES DIAGNOSTIC ULTRASOUND SYSTEMS CHISON MEDICAL IMAGING CO., LTD. 510(k) NO: K121867(TRADITIONAL) ATTN: PHONE NO : NO. 8, XIANG NAN ROAD SHUO FANG, NSE DECISION MADE: 02-AUG-12 WUXI CH 214142 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: BT-200V VASCULAR DOPPLER BISTOS CO., LTD. 510(k) NO: K121267(TRADITIONAL) ATTN: YOUNG CHI PHONE NO : 973 278 5222 111 ELLISON STREET SE DECISION MADE: 02-AUG-12 PATERSON NJ 07505 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROSOFT AMALGA UIS IMAGE PROCESSING MODULE MICROSOFT CORP. 510(k) NO: K120734(TRADITIONAL) ATTN: ADRIENNE LENZ PHONE NO : 512 327 9997 611 WEST 5TH ST, THIRD FLOOR SE DECISION MADE: 02-AUG-12 AUSTIN TX 78701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LANX SPINAL FIXATION SYSTEM LANX, INC. 510(k) NO: K121940(SPECIAL) ATTN: PATRICK HUNT PHONE NO : 303 443 7500 310 INTERLOCKEN PARKWAY SUITE 120 SE DECISION MADE: 02-AUG-12 BROOMFIELD CO 80021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DRAGON LW SEDECAL SA 510(k) NO: K121410(SPECIAL) ATTN: DANIEL KAMM PHONE NO : 239 234 1735 8870 RAVELLO ST SE DECISION MADE: 02-AUG-12 NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEADWAY DUO MICROCATHETER MICROVENTION, INC. 510(k) NO: K120917(TRADITIONAL) ATTN: NAOMI GONG PHONE NO : 714 247 8055 1311 VALENCIA AVE SE DECISION MADE: 02-AUG-12 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERIFUSE CATHETER SMITHS MEDICAL ASD, INC. 510(k) NO: K121525(TRADITIONAL) ATTN: CHRISTINE LLOYD PHONE NO : 781 763 9404 10 BOWMAN DR. SE DECISION MADE: 02-AUG-12 KEENE NH 03431 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE VIVYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) SHIJAZHUANG JIUYUAN PLASTIC CO., L510(k) NO: K121157(TRADITIONAL) ATTN: CHU XIAOAN PHONE NO : 861 082 387441 RM 1606 BLDG. 1 JIANXIANG YUAN SE DECISION MADE: 02-AUG-12 BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SENSUS NEUROMETRIX, INC. 510(k) NO: K121184(TRADITIONAL) ATTN: RAINER MAAS PHONE NO : 781 890 9989 62 FOURTH AVE. SE DECISION MADE: 02-AUG-12 WALTHAM MA 02451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MYSAFETY SYRINGE MEDICALCHAIN INTERNARTIONAL CORPOR510(k) NO: K113673(TRADITIONAL) ATTN: ROBIN HWANG PHONE NO : 805 376 0372 1808 SEABREEZE COURT SE DECISION MADE: 03-AUG-12 THOUSAND OAKS CA 91320 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM650 BIONIME CORPORATION 510(k) NO: K120423(TRADITIONAL) ATTN: FENG-YU LEE PHONE NO : 949 951 3046 2700 LAPAZ ROAD SUITE 266B SE DECISION MADE: 03-AUG-12 MISSION VIEJO CA 92691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MASTERKA 40 MASTERKA 35 MASTERKA 30 FCI SAS (FRANCE CHIRURGIE INSTRUME510(k) NO: K113536(TRADITIONAL) ATTN: BARBARA FRANT PHONE NO : 513 961 8200 3308 JEFFERSON AVENUE UPPER LEVEL SE DECISION MADE: 03-AUG-12 CINCINNATI OH 45220 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 8MP COLOR LCD MONITOR, REDIFORCE RX840 EIZO NANAO CORPORATION 510(k) NO: K120451(TRADITIONAL) ATTN: HIROAKI HASHIMOTO PHONE NO : 817 627 42468 153 SHIMOKASHIWANO SE DECISION MADE: 03-AUG-12 HAKUSAN JA 924-8566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IDENTIFY HUMEDIQ GMBH 510(k) NO: K112692(TRADITIONAL) ATTN: MORITZ HOYER PHONE NO : 49 895 49989024 BAHNHOFSTRABE 108 SE DECISION MADE: 03-AUG-12 GRAFELFING GM 82166 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOLAND G-423 GLOOD GLUCOSE MONITORING SYSTEM TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K113077(TRADITIONAL) ATTN: LINDA KO PHONE NO : 886 266 258188 3F, 5F, NO 127 WUGONG 2ND RD WUGU SE DECISION MADE: 03-AUG-12 NEW TAIPEI CITY TW 24888 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR 8850XX KEYPORT TROCAR 8850XX SEALING CA RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K120898(TRADITIONAL) ATTN: RON HASELHORST PHONE NO : 847 913 1113 353 CORPORATE WOODS PKWY. SE DECISION MADE: 03-AUG-12 VERNON HILLS IL 60061 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM CODMAN & SHURTLEFF, INC. 510(k) NO: K122118(SPECIAL) ATTN: KATHY STRANGE PHONE NO : 508 828 3257 325 PARAMOUNT DR. SE DECISION MADE: 03-AUG-12 RAYNHAM MA 02767 0350 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED BOSTON SCIENTIFIC CORP. 510(k) NO: K121048(TRADITIONAL) ATTN: JANIS F TARANTO PHONE NO : 508 683 4560 100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 03-AUG-12 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NITRILE EXAMINATION GLOVES (WHITE, BLUE AND BLACK) TEKMEDIC (M) SDN BHD 510(k) NO: K121192(TRADITIONAL) ATTN: PATRICK LEONG PHONE NO : 606 351 0959 PLOT 4, TANJUNG KLING SE DECISION MADE: 03-AUG-12 TANJUNG BRUAS JETTY, TANJUNG KLING510(k) STATEMENT DEVICE: POWER-FREE NITRILE PATIENT EXAMINATION GLOVES SHANDONG JUNCHI MEDICAL PRODUCTS C510(k) NO: K121526(TRADITIONAL) ATTN: CECILY SHENG PHONE NO : 909 548 4828 12390 EAST END AVE. SE DECISION MADE: 03-AUG-12 CHINO CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LTM-LABAROSCOPIC SURGICAL MESH LIFECELL CORP. 510(k) NO: K121289(TRADITIONAL) ATTN: MARK R JAKUBOWSKI PHONE NO : 908 809 7719 ONE MILLENNIUM WAY SE DECISION MADE: 03-AUG-12 BRANCHBURG NJ 08876 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PICC CONVENIENCE KIT NAVILYST MEDICAL, INC. 510(k) NO: K121990(SPECIAL) ATTN: MARION W GORDON PHONE NO : 508 949 1129 26 FOREST STREET SE DECISION MADE: 03-AUG-12 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BE PLUS LTM AMPLIFIER GWI AMPLIFIER EB NEURO, S.P.A. 510(k) NO: K121996(SPECIAL) ATTN: ALLISON SCOTT PHONE NO : 317 569 9500 9001 WESLEYAN ROAD SE DECISION MADE: 03-AUG-12 INDIANAPOLIS IN 46268 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UROPLASTY RIGID ENDOSCPIC NEEDLES UROPLASTY, INC. 510(k) NO: K121337(TRADITIONAL) ATTN: EMILY METCALFE PHONE NO : 952 426 6184 5420 FELTL RD. SE DECISION MADE: 03-AUG-12 MINNETONKA MN 55343 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHANGRING WUHU SNNA MEDICAL TREATMENT APPLIA510(k) NO: K121789(TRADITIONAL) ATTN: CYNTHIA NOLTE PHONE NO : 508 643 0434 49 PLAIN STREET SE DECISION MADE: 03-AUG-12 N. ATTLEBORO MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TREVO RETRIEVER CONCENTRIC MEDICAL, INC. 510(k) NO: K120961(TRADITIONAL) ATTN: KIRSTEN VALLEY PHONE NO : 650 938 2100 301 EAST EVELYN AVE. SE DECISION MADE: 03-AUG-12 MOUNTAIN VIEW CA 94041 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENT ALFA WASSERMANN DIAGNOSTIC TECHNOL510(k) NO: K113437(TRADITIONAL) ATTN: HYMAN KATZ PHONE NO : 973 852 0158 4 HENDERSON DRIVE SE DECISION MADE: 06-AUG-12 WEST CALDWELL NJ 07006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ET II BIO-SA FIXTURE SYSTEM HIOSSEN INC. 510(k) NO: K112532(TRADITIONAL) ATTN: PATRICK LIM PHONE NO : 888 678 0001 85 BEN FAIRLESS DRIVE SE DECISION MADE: 06-AUG-12 FAIRLESS HILLS PA 19030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: G-SCAN BRIO ESAOTE, S.P.A. 510(k) NO: K122006(SPECIAL) ATTN: ALLISON SCOTT, RAC PHONE NO : 317 569 9500 9001 WESLEYAN ROAD SUITE 200 SE DECISION MADE: 06-AUG-12 INDIANAPOLIS IN 46268 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEART SYNC PEDIATRIC PHYSIO AED PAD HEART SYNC INC. 510(k) NO: K120536(TRADITIONAL) ATTN: DANIEL KAMM PHONE NO : 239 234 1735 8870 RAVELLO CT SE DECISION MADE: 06-AUG-12 NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN DENTSPLY INTERNATIONAL INC. 510(k) NO: K121698(TRADITIONAL) ATTN: HELEN LEWIS PHONE NO : 717 849 4229 221 WEST PHILADELPHIA ST. SUITE 60SE DECISION MADE: 06-AUG-12 YORK PA 17404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS STERILMED, INC. 510(k) NO: K121158(TRADITIONAL) ATTN: JASON SKRAMSTED PHONE NO : 763 488 3483 11400 73RD AVE. NORTH SE DECISION MADE: 06-AUG-12 MAPLE GROVE MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITEK 2 AST- GRAM POSTIVE PENICILLIN FOR STREPTOCOCCUS PNEUMONIAE BIOMERIEUX, INC. 510(k) NO: K113783(TRADITIONAL) ATTN: ELIZABETH LANDON PHONE NO : 919 620 2329 100 RODOLPHE ST SE DECISION MADE: 07-AUG-12 DURHAM NC 27712 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUCTION LIPOLASTY ACCESSORIES NORMAN M. BLACK III 510(k) NO: K113795(TRADITIONAL) ATTN: NORMAN BLACK PHONE NO : 404 428 1813 2759 HAWTHORNE DRIVE NE SE DECISION MADE: 07-AUG-12 ATLANTA GA 30345 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NAUTILUS SPINAL SYSTEM LIFE SPINE 510(k) NO: K111953(SPECIAL) ATTN: RANDY LEWIS PHONE NO : 847 884 6117 2401 W. HASSELL RD. SUITE 1535 SE DECISION MADE: 07-AUG-12 HOFFMAN ESTATES IL 60169 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD BACTEC PLUS PRIME AEROBIC/F BECTON, DICKINSON AND COMPANY 510(k) NO: K120994(TRADITIONAL) ATTN: PAUL SWIFT PHONE NO : 410 316 4905 7 LOVETON CIRCLE, MC 614 SE DECISION MADE: 07-AUG-12 SPARKS MD 21152 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM ZIMMER MEDIZINSYSTEMS GMBH 510(k) NO: K121059(ABBREVIATED) ATTN: ARMIN PETRASCHKA PHONE NO : 497 319761 140 JUNKERSSTRASSE 9 SE DECISION MADE: 07-AUG-12 NEU-ULM GM 89231 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SMITH & NEPHEW, INC. TOTAL KNEE SYSTEM INSTRUMENTATION SMITH & NEPHEW, INC. 510(k) NO: K121393(TRADITIONAL) ATTN: GINO ROUSS PHONE NO : 901 399 6707 1450 BROOKS RD. SE DECISION MADE: 07-AUG-12 MEMPHIS TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IDS-ISYS IGF-I CALIBRATION VERIFIERS IMMUNODIAGNOSTIC SYSTEMS LTD. 510(k) NO: K122141(ABBREVIATED) ATTN: MICK FENTON PHONE NO : 44 191 5190660 10 DIDCOT WAY, BOLDEN BUSINESS PARSE DECISION MADE: 07-AUG-12 BOLDON, TYNE & WEAR UK NE35 9PD510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KERATOR KJ MEDITECH CO., LTD 510(k) NO: K112787(TRADITIONAL) ATTN: PRICILLA CHUNG PHONE NO : 714 869 3080 951 STARBUCK ST. UNIT J SE DECISION MADE: 08-AUG-12 FULLERTON CA 92833 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEUTROPHASE ANTIMICROBIAL WOUND CLEANSER NOVABAY PHARMACEUTICALS 510(k) NO: K113820(TRADITIONAL) ATTN: SHEILA W PICKERING PHONE NO : 650 279 0668 2081 LONGDEN CIRCLE SE DECISION MADE: 08-AUG-12 LOS ALTOS CA 94024 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KENT CAMERA KENT IMAGING INC. 510(k) NO: K113507(TRADITIONAL) ATTN: DARRELL BARNHART PHONE NO : 403 455 7610 1440, 720- 13TH AVENUE SW SE DECISION MADE: 08-AUG-12 CALGARY CA T2R 1M5 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNBALLOON NON-OCCLUSIVE MODELING CATHETER LEMAITRE VASCULAR INC. 510(k) NO: K121839(SPECIAL) ATTN: ANDREW HODGKINSON PHONE NO : 781 221 2266 63 SECOND AVENUE SE DECISION MADE: 08-AUG-12 BEDFORD MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTEOSYMBIONICS PEEK CRANIAL IMPLANT OSTEOSYMBIONICS, LLC 510(k) NO: K121102(TRADITIONAL) ATTN: ELAINE DUNCAN PHONE NO : 715 549 6035 P.O. BOX 560 SE DECISION MADE: 08-AUG-12 STILLWATER MN 55082 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLASHPAK SYMMETRY MEDICAL 510(k) NO: K113776(TRADITIONAL) ATTN: ROBERT JOHNSON PHONE NO : 508 998 4464 61 JOHN VERTENTE BLVD SE DECISION MADE: 08-AUG-12 NEW BEDFORD MA 02745 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH APTUS ENDOSYSTEMS, INC. 510(k) NO: K121168(TRADITIONAL) ATTN: BURT GOODSON PHONE NO : 408 530 9050 777 N. PASTORIA AVE. SE DECISION MADE: 08-AUG-12 SUNNYVALE CA 94085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REFORM PEDICLE SCREW SYSTEM SPINAL USA 510(k) NO: K121172(SPECIAL) ATTN: J.D. WEBB PHONE NO : 512 388 0199 2050 EXECUTIVE DR. SE DECISION MADE: 08-AUG-12 PEARL MS 39208 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONVEY GUIDING CATHETER PENDRACARE INTERNATIONAL, B.V. 510(k) NO: K120585(TRADITIONAL) ATTN: TOM NOLAN PHONE NO : 919 878 7888 7205 LAKETREE DR SE DECISION MADE: 08-AUG-12 RALEIGH NC 27615 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONICAL CONNECTION IMPLANTS MIS IMPLANTS TECHNOLOGIES LTD. 510(k) NO: K112162(TRADITIONAL) ATTN: IMAN KHORSHID PHONE NO : 972 490 16800 BAR LEV INDUSTRIAL PARK P.O. BOX 7SE DECISION MADE: 08-AUG-12 BAR LEV INDUSTRIAL PARK IS 2015510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XENX XENOLITH MEDICAL 510(k) NO: K113692(TRADITIONAL) ATTN: OFER ZIGMAN PHONE NO : 972 868 11761 1 LESHEM, P.O. BOX 720 SE DECISION MADE: 09-AUG-12 KITYAT-GAT IS 82000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH FUJI SYSTEMS CORP. 510(k) NO: K120781(TRADITIONAL) ATTN: PAUL MASON PHONE NO : 858 414 0606 3250 SECOND AVENUE SE DECISION MADE: 09-AUG-12 SAN DIEGO CA 92103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSIGNIA ORMCO CORP. 510(k) NO: K121524(TRADITIONAL) ATTN: WENDY GARMAN PHONE NO : 714 516 7602 1717 WEST COLLINS AVENUE SE DECISION MADE: 09-AUG-12 ORANGE CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORACLE POSTERIOR CERVIAL FIXATION SYSTEM ACCEL SPINE 510(k) NO: K121136(TRADITIONAL) ATTN: DANIEL CHON PHONE NO : 800 713 9489 14850 Quorum Dr Ste 220 SE DECISION MADE: 09-AUG-12 Dallas TX 75254 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRAWFORD BIOCANALICULUS INTUBATION FCI SAS (FRANCE CHIRURGIE INSTRUME510(k) NO: K121142(TRADITIONAL) ATTN: BARBARA FANT PHONE NO : 513 961 8200 3308 JEFFERSON AVENUE UPPER LEVEL SE DECISION MADE: 09-AUG-12 CINCINNATI OH 45220 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROFEMUR Z REVISION HIP STEM WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K121221(SPECIAL) ATTN: YUAN LI PHONE NO : 901 867 4146 5677 AIRLINE RD. SE DECISION MADE: 09-AUG-12 ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ESPIN NLT SPINE LTD 510(k) NO: K120553(TRADITIONAL) ATTN: JOHN J SMITH PHONE NO : 202 637 3638 555 THIRTEENTH STREET NW SE DECISION MADE: 09-AUG-12 WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORACLE MIS SPINAL FIXATION SYSTEM ACCEL SPINE 510(k) NO: K120714(TRADITIONAL) ATTN: DANIEL CHON PHONE NO : 800 713 9489 14850 Quorum Dr Ste 220 SE DECISION MADE: 09-AUG-12 Dallas TX 75254 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE LATEX EXAMINATION GLOVES KHAI HOAN JOINT STOCK COMPANY 510(k) NO: K113685(TRADITIONAL) ATTN: TERENCE LIM PHONE NO : 840 650 591220 CAU SAT HAMPLET, LAI HUNG COMMUNE,SE DECISION MADE: 10-AUG-12 BINH DUONG PROVINCE VM VM 510(k) STATEMENT DEVICE: ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT ALFA WASSERMANN DIAGNOSTIC TECHNOL510(k) NO: K113389(TRADITIONAL) ATTN: HYMAN KATZ PHONE NO : 973 852 0158 4 HENDERSON DRIVE SE DECISION MADE: 10-AUG-12 WEST CALDWELL NJ 07006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIFECELL TISSUE EXPANDER LIFECELL CORP. 510(k) NO: K112534(TRADITIONAL) ATTN: KRISTEN MEANY PHONE NO : 908 947 1116 ONE MILLENNIUM WAY SE DECISION MADE: 10-AUG-12 BRANCHBURG NJ 08876 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVANTAGE-STRAND/ADVANTAGE-LOAD BRACHYTHERAPY KIT ISOAID, L.L.C. 510(k) NO: K113210(TRADITIONAL) ATTN: BENJAMIN ROEDELL PHONE NO : 727 815 3262 7824 CLARK MOODY BLVD. SE DECISION MADE: 10-AUG-12 PORT RICHEY FL 34668 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOPSY DIGIT S BIOPSY SL GIOTTO USA, LLC 510(k) NO: K113607(TRADITIONAL) ATTN: NICOLAAS BESSELING PHONE NO : 949 466 7472 81 SEACOUNTRY LANE SE DECISION MADE: 10-AUG-12 RANCHO SANTA MARGARITA CA 92688 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDICAL AIR COMPRESSOR ORICARE, INC. 510(k) NO: K113338(TRADITIONAL) ATTN: DAVID JAMISON PHONE NO : 215 538 2470 1900 AM DRIVE SE DECISION MADE: 10-AUG-12 QUAKERTOWN PA 18951 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WIRELESS IMAGE TRANSMITTER UNIT OLYMPUS MEDICAL SYSTEMS CORP. 510(k) NO: K120278(TRADITIONAL) ATTN: SHERI MUSGNUNG PHONE NO : 484 896 3147 3500 CORPORATE PARKWAY P.O. BOX 61SE DECISION MADE: 10-AUG-12 CENTER VALLEY PA 18034 0610 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY FEMORAL NAIL - ASIA SHORT ZIMMER GMBH 510(k) NO: K120715(SPECIAL) ATTN: STEPHEN H MCKELVEY PHONE NO : 574 372 4944 P.O. BOX 708 SE DECISION MADE: 10-AUG-12 WARSAW IN 46581 0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SCEPTER C OCCLUSION BALLOON CATHETER MICRO VENTION, INC. 510(k) NO: K121785(TRADITIONAL) ATTN: NAOMI GONG PHONE NO : 714 247 8055 1311 VALENCIA AVENUE SE DECISION MADE: 10-AUG-12 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECT PREVENTICE, INC. 510(k) NO: K121197(TRADITIONAL) ATTN: DREW PALIN PHONE NO : 507 322 2712 2765 COMMERCE DRIVE NW SUITE 220 SE DECISION MADE: 10-AUG-12 ROCHESTER MN 55901 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NITRILE EXAMINATION GLOVE, POWDER FREE (BLUE, BLACK OR WHITE) MATANG MFG. SDN. BHD. 510(k) NO: K121368(TRADITIONAL) ATTN: LESLIE LEONG PHONE NO : 606 263 3128 LOT 10, KAWASAN PERINDUSTRIAN SERKSE DECISION MADE: 10-AUG-12 MERLIMAU, MELAKA MY 77300 510(k) STATEMENT DEVICE: LUBE JELLY SURINGE NURSE ASSIST, INC. 510(k) NO: K121390(TRADITIONAL) ATTN: BILL KANEWSKE PHONE NO : 817 231 1300 3400 Northern Cross Blvd SE DECISION MADE: 10-AUG-12 Fort Worth TX 76137 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR SEJOY ELECTRONICS & INSTRUMENTS CO510(k) NO: K120554(TRADITIONAL) ATTN: REN YUNHUA PHONE NO : 865 718 1957767 WEST LAKE ECONOMY & TECHNOLOGY ZONSE DECISION MADE: 10-AUG-12 HANGZHOU, ZHEJIANG CH 310030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AIMAGO EASYLDI MICROCIRCULATION CAMERA AIMAGO SA 510(k) NO: K121429(TRADITIONAL) ATTN: MARC ANDRE PHONE NO : 412 151055 61 PARC SCIENTIFIQUE EPFL, PSE-D, 4THSE DECISION MADE: 10-AUG-12 LAUSANNE SZ 1015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMFORT EZ SIMPLE DIAGNOSTICS, INC. 510(k) NO: K121632(TRADITIONAL) ATTN: DANIEL KAMM PHONE NO : 239 234 1735 8870 RAVELLO CT SE DECISION MADE: 10-AUG-12 NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ET/SS IMPLANT SYSTEM OSSTEM IMPLANT CO.,LTD 510(k) NO: K120847(SPECIAL) ATTN: PATRICK LIM PHONE NO : 888 678 0001 85 BEN FAIRLESS DR. SE DECISION MADE: 10-AUG-12 FAIRLESS HILLS PA 19030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: C7 ANTERIOR CERVICAL INTERVERTEBRAL FUSION CAGE MEDYSSEY CO., LTD. 510(k) NO: K121320(TRADITIONAL) ATTN: MICHAEL KVITNITSKY PHONE NO : 847 982 0100 8001 N. LINCOLN AVE SUITE 401 SE DECISION MADE: 10-AUG-12 SKOKIE IL 60077 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MULTIX FUSION SIEMENS MEDICAL SOLUTION 510(k) NO: K121513(SPECIAL) ATTN: PATRICIA D JONES PHONE NO : 610 448 3536 51 VALLEY STREAM PKWY. SE DECISION MADE: 10-AUG-12 MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPIRALE DRUG DELIVERY SYSTEM ARMSTRONG MEDICAL LTD. 510(k) NO: K111246(TRADITIONAL) ATTN: IAN STEWART PHONE NO : 440 287 0356029 WATTSTOWN BUSINESS PARK NEWBRIDGE SE DECISION MADE: 10-AUG-12 COLERAINE EI BT52 1BS 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMRIS ONCOLOGY PACKAGE IMRIS, INC. 510(k) NO: K121997(TRADITIONAL) ATTN: SANJAY SHAH PHONE NO : 204 480 7070 100-1370 SONY PLACE SE DECISION MADE: 10-AUG-12 WINNIPEG, MB CA R3T 1N5 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CERASORB PLUS RIEMSER ARZNEIMITTEL AG 510(k) NO: K120152(ABBREVIATED) ATTN: JAMES M CLINTON PHONE NO : 919 247 0479 5105 FAIROAKS RD. SE DECISION MADE: 13-AUG-12 DURHAM NC 27712 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2 FUJINON, INC. 510(k) NO: K120446(TRADITIONAL) ATTN: MARK JOB PHONE NO : 763 682 4139 10 HIGH POINT DR. SE DECISION MADE: 13-AUG-12 WAYNE NJ 07470 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ERISMA-LP CLARIANCE 510(k) NO: K120469(TRADITIONAL) ATTN: WILLIAM JACKSON PHONE NO : 678 341 9581 3101 NEAL COURT SE DECISION MADE: 13-AUG-12 CUMMING GA 30041 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JOURNEY II CR KNEE SYSTEM SMITH & NEPHEW, INC. 510(k) NO: K121443(ABBREVIATED) ATTN: SHEREEN MYERS PHONE NO : 901 399 6325 1450 BROOKS RD. SE DECISION MADE: 13-AUG-12 MEMPHIS TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NC QUANTUM APEX PTCA DILATATION CATHETER (MONORAIL) BOSTON SCIENTIFIC CORP. 510(k) NO: K121667(SPECIAL) ATTN: LAURA J LIND PHONE NO : 763 494 2664 ONE SCIMED PLACE SE DECISION MADE: 13-AUG-12 MAPLE GROVE MN 55311 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12 CELLERATION, INC. 510(k) NO: K122246(SPECIAL) ATTN: KATHY SIMPSON PHONE NO : 952 224 8700 6321 BURY DRIVE, STE 15 SE DECISION MADE: 13-AUG-12 EDEN PRAIRIE MN 55346 510(k) STATEMENT DEVICE: SURGICLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER COVALON TECHNOLOGIES, INC. 510(k) NO: K121819(TRADITIONAL) ATTN: CHRISTOPHER FREDRIC PHONE NO : 905 568840 0 405 BRITANNIA RD. EAST SUITE 106 SE DECISION MADE: 13-AUG-12 MISSISSAUGA, ONTARIO CA L4Z 3E6510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOHARNESS ZEPHYR TECHNOLOGY CORPORATION 510(k) NO: K113045(TRADITIONAL) ATTN: RICHARD KEEN PHONE NO : 203 329 2700 1151 HOPE STREET SE DECISION MADE: 14-AUG-12 STAMFORD CT 06907 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITS THOMAS MEDICAL PRODUCTS, INC. 510(k) NO: K120158(TRADITIONAL) ATTN: TIM STOUDT PHONE NO : 610 651 5000 65 GREAT VALLEY PKWY. SE DECISION MADE: 14-AUG-12 MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONNECTED CARE CLINICAL APPLICATION WATERMARK MEDICAL INC 510(k) NO: K120320(TRADITIONAL) ATTN: MICHAEL J LEIGH PHONE NO : 262 957 6797 1750 Clint Moore rd, Suite 101 SE DECISION MADE: 14-AUG-12 Boca Raton FL 33487 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: C100 WRINKLE REDUCTION DEVICE SILVER BAY, LLC 510(k) NO: K112362(TRADITIONAL) ATTN: ROBERT WAGNER PHONE NO : 865 982 5552 1131 ANTHEM VIEW LANE SE DECISION MADE: 14-AUG-12 KNOXVILLE TN 37922 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIRECT LDL/HDL CHOLESTEROL CALIBRATOR RANDOX LABORATORIES LIMITED 510(k) NO: K122126(TRADITIONAL) ATTN: PAULINE ARMSTRONG PHONE NO : 440 289 4422413 34 DIAMOND ROAD SE DECISION MADE: 14-AUG-12 CRUMLIN ANTRIM GB BT29 4QY 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXACTRAC X-RAY X-RAY BRAINLAB AG 510(k) NO: K120789(TRADITIONAL) ATTN: ALEXANDER SCHWIERSCH PHONE NO : 490 899 915680 KAPELLENSTRASSE 12 SE DECISION MADE: 14-AUG-12 FELDKIRCHEN GM 85622 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DYNAFLEX DYNA FLEX 510(k) NO: K121396(TRADITIONAL) ATTN: MATTHEW MALABEY PHONE NO : 314 426 4020 10403 International Plaza Dr. SE DECISION MADE: 14-AUG-12 Northwest Plaza MO 63074 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AGILITY STEERABLE GUIDEWIRE NEUROSCOUT STEERABLE GUDIEWIRE CODMAN & SHURTLEFF, INC. 510(k) NO: K121776(TRADITIONAL) ATTN: JOAN BARTLE PHONE NO : 508 828 2840 325 PARAMOUNT DR. SE DECISION MADE: 14-AUG-12 RAYNHAM MA 02767 0350 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VARIOECO THOMMEN MEDICAL, AG 510(k) NO: K121334(TRADITIONAL) ATTN: LINDA K SCHULZ PHONE NO : 858 792 1235 11234 EL CAMINO REAL, STE. 200 SE DECISION MADE: 14-AUG-12 SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TABLET COMMANDER CARDIOCOM LLC 510(k) NO: K122285(TRADITIONAL) ATTN: DANIEL L COSENTINO PHONE NO : 888 243 8881 7980 CENTURY BLVD. SE DECISION MADE: 14-AUG-12 CHANHASSEN MN 55317 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: VIALOK SINGLE VIAL ACCESS DEVICE VENTED YUKON MEDICAL, LLC 510(k) NO: K122265(TRADITIONAL) ATTN: PHONE NO : 4819-400 EMPEROR BLVD SE DECISION MADE: 14-AUG-12 DURHAM NC 27703 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ALTOMEC ARTHROSCOPE ALTOMEC ENDOSCOPY INC 510(k) NO: K112548(ABBREVIATED) ATTN: DARREN REEVES PHONE NO : 804 307 7706 7305 HANCOCK VILLAGE DR. SUITE 109SE DECISION MADE: 15-AUG-12 CHESTERFIELD VA 23832 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014" GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.18" G TRIREME MEDICAL INC 510(k) NO: K122070(SPECIAL) ATTN: SHIVA ARDAKANI PHONE NO : 925 931 1300 7060 KNOLL CENTER PARKWAY SUITE 30SE DECISION MADE: 15-AUG-12 PLEASANTON CA 94566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GID 700 THE GID GROUP, INC. 510(k) NO: K120902(TRADITIONAL) ATTN: LEWIS WARD PHONE NO : 303 530 3279 4655 KIRKWOOD COURT SE DECISION MADE: 15-AUG-12 BOULDER CO 80301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VISI MOBILE MONITORING SYSTEM SOTERA WIRELESS, INC 510(k) NO: K122036(TRADITIONAL) ATTN: EBEN GORDON PHONE NO : 858 373 4841 9444 WAPLES STREET SUITE 280 SE DECISION MADE: 15-AUG-12 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ARMADA 14XXT PTA CATHETER ABBOTT VASCULAR 510(k) NO: K121352(TRADITIONAL) ATTN: IVALEE COHEN PHONE NO : 408 845 0682 3200 LAKESIDE DRIVE SE DECISION MADE: 15-AUG-12 SANTA CLARA CA 95054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 4CIS VANE SPINE SYSTEM SOLCO BIOMEDICAL CO., LTD. 510(k) NO: K121615(SPECIAL) ATTN: SAEYOUNG AHN PHONE NO : 301 646 6602 9700 GREAT SENECA HIGHWAY STE 302 SE DECISION MADE: 15-AUG-12 ROCKVILLE MD 20850 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXINI EXINI DIAGNOSTICS AB 510(k) NO: K122205(TRADITIONAL) ATTN: ALLISON SCOTT PHONE NO : 317 569 9500 9001 WESLEYAN ROAD SUITE 200 SE DECISION MADE: 15-AUG-12 INNDIANAPOLIS IN 46268 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MOVATION KNEE SYSTEM ENCORE MEDICAL, L.P. 510(k) NO: K121727(SPECIAL) ATTN: WILLIAM GARZON PHONE NO : 512 834 6391 9800 METRIC BLVD. SE DECISION MADE: 15-AUG-12 AUSTIN TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WITOUCH PRO HOLLYWOG, LLC 510(k) NO: K120398(TRADITIONAL) ATTN: MICHAEL W TREAS PHONE NO : 423 305 7778 2830 AMMICOLA HIGHWAY SE DECISION MADE: 16-AUG-12 CHATTANOOGA TN 37406 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS) SPINE VIEW, INC. 510(k) NO: K121548(SPECIAL) ATTN: DIANA DEGREGORIO PHONE NO : 925 980 8047 48810 Kato Rd. Suite 100E SE DECISION MADE: 16-AUG-12 Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRATIFY JCV DXSELECT FOCUS DIAGNOSTICS, INC. 510(k) NO: K120986(TRADITIONAL) ATTN: TARA VIVIANI PHONE NO : 562 240 6615 11331 Valley View Street SE DECISION MADE: 16-AUG-12 CYPRESS CA 90630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RESPROCESSED SERFAS ENERGY PROBE STRYKER SUSTAINABILITY SOLUTIONS 510(k) NO: K121855(TRADITIONAL) ATTN: ERIC VARTY PHONE NO : 888 888 3433 1810 WEST DRAKE DRIVE SE DECISION MADE: 16-AUG-12 TEMPE AZ 85283 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITEK 2 AST-ST CEFOTAXIME BIOMERIEUX, INC. 510(k) NO: K121863(TRADITIONAL) ATTN: ELIZABETH LANDON PHONE NO : 919 650 2329 100 RODOLPHE ST SE DECISION MADE: 16-AUG-12 DURHAM NC 27712 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM TOSHIBA MEDICAL SYSTEMS COPORATION510(k) NO: K121422(SPECIAL) ATTN: CHARLEMAGNE CHUA PHONE NO : 714 669 7896 2441 MICHELLE DR SE DECISION MADE: 16-AUG-12 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL FLAT PANEL X-RAY DETECTOR/1717SGC RAYENCE CO., LTD 510(k) NO: K122182(SPECIAL) ATTN: DAVE KIM PHONE NO : 713 467 2607 12946 KIMBERLEY LN SE DECISION MADE: 16-AUG-12 HOUSTON TX 77079 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OEC 9900 ELITE GE HEALTHCARE SURGERY GE OEC MEDIC510(k) NO: K122234(SPECIAL) ATTN: GERALD BUSS PHONE NO : 801 517 6591 384 WRIGHT BROTHERS DRIVE SE DECISION MADE: 16-AUG-12 SALT LAKE CITY UT 84116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DX-D IMAGING PACKAGE AGFA HEALTHCARE N.V. 510(k) NO: K121095(TRADITIONAL) ATTN: DAVID LEDWIG PHONE NO : 828 862 8555 PO BOX 1927 SE DECISION MADE: 16-AUG-12 BREVARD NC 28712 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CHORD-X EPTFE SUTURE ON-XLIFETECHNOLOGIES 510(k) NO: K121173(ABBREVIATED) ATTN: JOHN ELY PHONE NO : 512 339 8000 1300 EAST ANDERSON LANE BLDG B SE DECISION MADE: 16-AUG-12 AUSTIN TX 78752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOJET JET SOFT SRL 510(k) NO: K122329(TRADITIONAL) ATTN: PETER-M KLEWS PHONE NO : 494 133 510185 STR. ANASTTASIE PANU NR. 6 SE DECISION MADE: 16-AUG-12 BUCHAREST RO 031164 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: TAPERLOC COMPLETE SIZE 4MM AND XR 123 BIOMET MANUFACTURING CORP. 510(k) NO: K120030(TRADITIONAL) ATTN: BECKY EARL PHONE NO : 574 267 6639 56 EAST BELL DRIVE P.O. BOX 587 SE DECISION MADE: 17-AUG-12 WARSAW IN 46581 0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEBULAE I NORTHGATE TECHNOLOGIES INC. 510(k) NO: K120151(TRADITIONAL) ATTN: CASEY KUREK PHONE NO : 224 856 2222 1591 Scottsdale Court SE DECISION MADE: 17-AUG-12 Elgin IL 60123 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDLINE HIGH PRESSURE INJECTION TUBING MEDLINE, INDUSTRIES, INC. 510(k) NO: K120008(TRADITIONAL) ATTN: MATT CLAUSEN PHONE NO : 847 643 4785 ONE MEDLINE PLACE SE DECISION MADE: 17-AUG-12 MUNDELEIN IL 60060 510(k) STATEMENT DEVICE: HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP) HITACHI CHEMICAL DIAGNOSTICS, INC.510(k) NO: K113809(TRADITIONAL) ATTN: ERICKA B AMMIRATI PHONE NO : 650 949 2768 575 SHIRLYNN COURT SE DECISION MADE: 17-AUG-12 LOS ALTOS CA 94022 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CALAVIEW COLOR (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR MODIFICATION INNOVA VISION INC. 510(k) NO: K112373(TRADITIONAL) ATTN: JENNIFER REICH PHONE NO : 928 773 6340 2904 N. BOLDT DRIVE SE DECISION MADE: 17-AUG-12 FLAGSTAFF AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROAIRE SURGICAL INSTRUMENTS LLC MICROAIRE SURGICAL INSTRUMENTS, LL510(k) NO: K113128(ABBREVIATED) ATTN: DARREN REEVES PHONE NO : 804 307 7706 7305 HANCOCK VILLAGE DR SUITE 109 SE DECISION MADE: 17-AUG-12 CHESTERFIELD VA 23832 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LUNG VOLUME ANALYSIS TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K113715(TRADITIONAL) ATTN: PAUL BIGGINS PHONE NO : 714 669 7808 2441 MICHELLE DRIVE SE DECISION MADE: 17-AUG-12 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRELUDE 7F SHORT SHEATH INTRODUCER MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K122190(SPECIAL) ATTN: DAN CLARK PHONE NO : 801 316 4831 1600 WEST MERIT PKWY. SE DECISION MADE: 17-AUG-12 South Jordan UT 84095 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE NITRIE EXAMINATION GLOVES, ORANGE SHEN WEI (USA), INC. 510(k) NO: K120890(TRADITIONAL) ATTN: ALBERT LI PHONE NO : 540 429 8692 33278 CENTRAL AVE., SUITE 102 SE DECISION MADE: 17-AUG-12 UNION CITY CA 94587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIVID I DIAGNOSTIC ULTRASOUND SYSTEM, VIVID Q DIAGNOSTIC ULTRASOUND SYSTEM GE MEDICAL SYSTEM ISRAEL LTD. 510(k) NO: K121062(TRADITIONAL) ATTN: BRYAN BEHN PHONE NO : 414 721 4214 9900 INNOVATION DR SE DECISION MADE: 17-AUG-12 WAUWATOSA WI 53226 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: YA HORNG BLOOD PRESSURE MONITOR, YA HORNG BLOOD PRESSURE MONITOR, BLUETOOTH TRANSMISSION YA HORNG ELECTRONIC CO., LTD. 510(k) NO: K121025(TRADITIONAL) ATTN: JEN KE-MIN PHONE NO : 886 3 5208829 NO. 58, FU-CHIUN ST. SE DECISION MADE: 17-AUG-12 HSIN-CHU CITY TW 30067 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STGC CARDINAL SPINE, LLC 510(k) NO: K121176(TRADITIONAL) ATTN: KEVIN A THOMAS PHONE NO : 858 792 1235 11234 EL CAMINO REAL, SUITE 200 SE DECISION MADE: 17-AUG-12 SAN DIEGO CA 9213 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: A-V FOOT PUMP DALIAN LABTEK SCIENCE & DEVELOPMEN510(k) NO: K121718(TRADITIONAL) ATTN: DORIS DONG PHONE NO : 86 213 1261348 RM 1706 YUESHA, NO. 128 SONGLE RD,SE DECISION MADE: 17-AUG-12 SHANGHAI CH 201600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATRIUM FLIXENE IFG VASCULAR GRAFT ATRIUM MEDICAL CORP. 510(k) NO: K122138(SPECIAL) ATTN: MEGAN MCCAGH PHONE NO : 603 880 1433 5 Wentworth Dr SE DECISION MADE: 17-AUG-12 HUDSON NH 03051 510(k) STATEMENT DEVICE: LANX SPINAL FIXATION SYSTEM LANX, INC. 510(k) NO: K122145(SPECIAL) ATTN: MICHAEL FUNK PHONE NO : 303 443 7500 310 INTERLOCKEN PARKWAY SUITE 120 SE DECISION MADE: 17-AUG-12 BROOMFIELD CO 80021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OCTAVE SPEEDER HEAD TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K121910(SPECIAL) ATTN: PAUL BIGGINS PHONE NO : 714 669 7808 2441 MICHELLE DR SE DECISION MADE: 17-AUG-12 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OCTAVE SPEEDER SPINE TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K121911(SPECIAL) ATTN: PAUL BIGGINS PHONE NO : 714 669 7808 2441 MICHELLE DR SE DECISION MADE: 17-AUG-12 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRUETOME BOSTON SCIENTIFIC CORP. 510(k) NO: K122203(SPECIAL) ATTN: LAURIE PANNELLA PHONE NO : 508 683 4872 100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 17-AUG-12 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VENOFER PUMP RENAL SOLUTIONS INC. 510(k) NO: K121497(TRADITIONAL) ATTN: DAVID VANELLA PHONE NO : 724 720 2840 770 COMMONWEALTH DRIVE SUITE 101 SE DECISION MADE: 17-AUG-12 WARRENDALE PA 15086 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTO HYALUS GREEN LASER OPTO ELETRONICA S/A 510(k) NO: K111460(TRADITIONAL) ATTN: PAULO ANEAS LICHTI PHONE NO : 55 16 21067029 JOAQUIM A. R. DE SOUZA STREET 1071SE DECISION MADE: 20-AUG-12 SAO CARLOS, SAO PAULO BR 13630-510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AVS AS PEEK SPACER STRYKER SPINE 510(k) NO: K120486(TRADITIONAL) ATTN: SORAYA KING PHONE NO : 201 760 8296 2 PEARL COURT SE DECISION MADE: 20-AUG-12 ALLENDALE NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRASONIC NEBULIZER FOSHAN GAUNYING ELECTRONICS CO., L510(k) NO: K121154(TRADITIONAL) ATTN: GUENTER GINSBERG PHONE NO : 239 948 2001 11820 RED HIBISCUS DRIVE SE DECISION MADE: 20-AUG-12 BONITA SPRINGS FL 34135 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GRIDLOCK PLATING SYSTEM TRILLIANT SURGICAL LTD 510(k) NO: K121452(TRADITIONAL) ATTN: J.D. WEBB PHONE NO : 512 388 0199 1001 OAKWOOD BLVD SE DECISION MADE: 20-AUG-12 ROUND ROCK TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DYNATRON THERMOSTIM PROBE-DONE DYNATRONICS CORPORATION 510(k) NO: K120835(TRADITIONAL) ATTN: DOUGLAS SAMPSON PHONE NO : 801 568 7000 7030 PARK CENTRE DRIVE SE DECISION MADE: 20-AUG-12 SALT LAKE CITY UT 84121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE PAIN PILOT (A.K.A PAIN PILOT) HOLLYWOG, LLC 510(k) NO: K120500(TRADITIONAL) ATTN: MICHAEL W TREAS PHONE NO : 423 305 7778 2830 Amnicola Hwy SE DECISION MADE: 20-AUG-12 Chattanooga TN 37406 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VASOPRESS DVT LEG GARMENTS (STERILE) VASOPRESS DVT FOOT GARMENTS (STERILE) COMPRESSION THERAPY CONCEPTS 510(k) NO: K122179(SPECIAL) ATTN: LEONARD NASS PHONE NO : 732 544 0800 555 INDUSTRIAL WAY WEST SE DECISION MADE: 20-AUG-12 EATONTOWN NJ 07724 2298 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAMBA SCREW, 9MM DIA., 25MM LONG, SAMBIA SCREW, 9MM DIA., 30MM LONG, SAMBA SCREW 9MM DIA., 35MM LONG, SAMBA SCREW, 9MM D MEDICAL DESIGN LLC. 510(k) NO: K121148(TRADITIONAL) ATTN: KRISTI VONDRA PHONE NO : 605 275 1032 6709 S. MINNESOTA AVE. STE 204 SE DECISION MADE: 20-AUG-12 SIOUX FALLS SD 57108 2593 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WELKINS EMT/ICU TEMPERATURE MANAGERMENT SYSTEM WELKINS, LLC 510(k) NO: K121720(TRADITIONAL) ATTN: CHRISTOPHER BLODGETT PHONE NO : 207 449 6398 1430 BLUE OAKS BLVD SUITE 250 SE DECISION MADE: 20-AUG-12 ROSEVILLE CA 95747 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: TYSONBIO MD100 BLOOD GLUCSE MONITORING ,TYSONBIO MD100 PRO BLOOD GLUCISE MONITORING SYSTEM TYSON BIORESEARCH, INC. 510(k) NO: K112916(TRADITIONAL) ATTN: WEN-HAI TSAI PHONE NO : 886 375 85988 5F. #22, Ke E. Road III SCIENCE-BASE DECISION MADE: 21-AUG-12 CHU-NAN, TW 350 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MTA-FILLAPEX PAXMED INTERNATIONAL 510(k) NO: K113568(TRADITIONAL) ATTN: ALLISON KOMIYAMA PHONE NO : 11234 EL CAMINO SUITE 200 SE DECISION MADE: 21-AUG-12 SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUPERA VERITAS(R) INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM IDEV TECHNOLOGIES, INC. 510(k) NO: K111627(TRADITIONAL) ATTN: DARLENE GARNER PHONE NO : 281 525 2000 253 MEDICAL CENTER BLVD SE DECISION MADE: 21-AUG-12 WEBSTER TX 77598 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIRTUAL SLIDE SYSTEM, OLYMPUS VS800 SYSTEM OLYMPUS AMERICA INC. / SCIENTIFIC 510(k) NO: K111914(TRADITIONAL) ATTN: SHERI L MUSGNUNG PHONE NO : 484 896 3147 3500 CORPORATE PARKWAY P.O. BOX 61SE DECISION MADE: 21-AUG-12 CENTER VALLEY PA 18034 0610 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HY-CHLO(TM)WOUND SCRUB PATRIN PHARMA 510(k) NO: K113312(TRADITIONAL) ATTN: JAY S TRIVEDI PHONE NO : 800 936 3088 7817 BABB AVE. SE DECISION MADE: 21-AUG-12 SKOKIE IL 60077 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOSERVICE ENDOSCOPIC INSTRUMENTS & ACCESSORIES AND MINIMALLY INVASIVE GI AND GU DEVICES ENDOSERVICE OPTICAL INSTRUMENTS GM510(k) NO: K113062(TRADITIONAL) ATTN: ANDREA PECSI PHONE NO : 497 462 924051 SCHWARZWALDSTRASSE 5 SE DECISION MADE: 21-AUG-12 TUTTLINGEN GM 78532 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K121764(SPECIAL) ATTN: BRAD SHEALS PHONE NO : 901 396 3133 1800 PYRAMID PL. SE DECISION MADE: 21-AUG-12 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM, VIVID S6 DIAGNOSTIC ULTRASOUND SYSTEM GE MEDICAL SYSTEM ISRAEL LTD. 510(k) NO: K121063(TRADITIONAL) ATTN: BRYAN BEHN PHONE NO : 414 721 4214 9900 INNOVATION DR SE DECISION MADE: 21-AUG-12 WAUWATOSA WI 53226 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEVER CHOICE SIMPLE DIAGNOSTICS, INC. 510(k) NO: K120921(TRADITIONAL) ATTN: DANIEL KAMM PHONE NO : 239 234 1735 8870 RAVELLO CT SE DECISION MADE: 21-AUG-12 NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BONE PLUS BCP EAGLE EYE MEGAGEN IMPLANT CO., LTD 510(k) NO: K122240(SPECIAL) ATTN: APRIL LEE PHONE NO : 714 525 0114 325 N PUENTE ST. UNIT B SE DECISION MADE: 21-AUG-12 BREA CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GUARDIVA ANTIMICROBIAL HAEMSTATIC IV DRESSING HEMCON MEDICAL TECHNOLOGIES EUROPE510(k) NO: K121485(TRADITIONAL) ATTN: BARBARA MCGRATH PHONE NO : 503 245 0459 10575 SW CASCADE AVENUE SUITE 130 SE DECISION MADE: 21-AUG-12 PORTLAND OR 97223 4363 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTEOMED CRANIAL DISTRACTION SYSTEM OSTEOMED 510(k) NO: K121304(TRADITIONAL) ATTN: PIEDAD PENA PHONE NO : 972 677 4784 3885 Arapaho Rd SE DECISION MADE: 22-AUG-12 ADDISON TX 75001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELITECH CLINICAL SYSTEMS CK NAC SL ELITECHGROUP 510(k) NO: K122083(TRADITIONAL) ATTN: DEBRA K HUTSON PHONE NO : 425 482 5174 21720 23RD DR SE SUITE 150 SE DECISION MADE: 22-AUG-12 BOTHELL WA 98021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SWANNSHIDI BONE MARROW ASPIRATION NEEDLE ALLIANCE PARTNERS, LLC 510(k) NO: K121181(TRADITIONAL) ATTN: JENNIFER PALINCHIK PHONE NO : 440 933 8850 33490 PIN OAK PARKWAY SE DECISION MADE: 22-AUG-12 AVON LAKE OH 44012 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EDWARDS PERCUTANEOUS SHEATH INTRODUCER EDWARDS LIFESCIENCES, LLC. 510(k) NO: K121185(TRADITIONAL) ATTN: SPENCER WALKER PHONE NO : 801 565 6103 12050 LONE PEAK PKWY. SE DECISION MADE: 22-AUG-12 DRAPER UT 84020 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSPIRE 8F OXYGENATOR WITH INTEGRATED ARTERIAL FILTER & HARDSHELL RESERVOIR SORIN GROUP ITALIA S.R.L. 510(k) NO: K121536(TRADITIONAL) ATTN: SCOTT LIGHT PHONE NO : 303 467 6313 14401 W. 65TH WAY SE DECISION MADE: 22-AUG-12 ARVADA CO 80004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GENESYS PRESSFT SUTURE ANCHOR LINVATEC CORPORATION D/B/A CONMED 510(k) NO: K121890(SPECIAL) ATTN: LORNA K LINVILLE PHONE NO : 727 399 5396 11311 Concept Boulevard SE DECISION MADE: 22-AUG-12 LARGO FL 33773 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HARMONIC ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH + ADAPTIVE TISSUE TECHNOLOGY ETHICON ENDO-SURGERY, LLC 510(k) NO: K121550(TRADITIONAL) ATTN: MARCIA ARETZ PHONE NO : 513 337 7981 4545 CREEK ROAD SE DECISION MADE: 22-AUG-12 CINCINNATI OH 45242 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EON CALCIUM REGENT VITAL DIAGNOSTICS (MANUFACTURING) 510(k) NO: K120626(TRADITIONAL) ATTN: MELITA LAMBIRIS PHONE NO : 613 879 36300 189-199 BROWNS RD SE DECISION MADE: 22-AUG-12 NOBLE PARK AS 3174 510(k) STATEMENT DEVICE: XPRESS MULTI-SINUS DILATION TOOL ENTELLUS MEDICAL, INC. 510(k) NO: K121943(SPECIAL) ATTN: KAREN E PETERSON PHONE NO : 763 463 7066 3600 HOLLY LANE NORTH SUITE 40 SE DECISION MADE: 22-AUG-12 PLYMOUTH MN 55447 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROLYTE ELECTROLYTE ANALYZER DIAMOND DIAGNOSTICS, INC 510(k) NO: K121140(TRADITIONAL) ATTN: KATHY CRUZ PHONE NO : 508 429 0450 333 Fiske St SE DECISION MADE: 22-AUG-12 Holliston MA 01746 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYSTEM, X-RAY, STATIONARY BEIJING SINOPHARM HUNDRIC MEDILINE510(k) NO: K121854(TRADITIONAL) ATTN: DIANA HONG PHONE NO : 86 21 22815850 P.O. BOX 237-023 SE DECISION MADE: 22-AUG-12 SHANGHAI CH 200237 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LINEBACKER(TM) TRANSSEPTAL INTRODUCER, 53CM / 62CM / 72CM EP DYNAMICS, INC. 510(k) NO: K111603(TRADITIONAL) ATTN: ALBERT REGO PHONE NO : 949 770 8710 27001 LA PAZ ROAD SUITE #312 SE DECISION MADE: 23-AUG-12 MISSION VIEJO CA 92691 510(k) STATEMENT DEVICE: FREEDOM INGUINAL HERNIA IMPLANT INSIGHTRA MEDICAL 510(k) NO: K113552(TRADITIONAL) ATTN: WAYNE NODA PHONE NO : 949 215 1835 9200 IRVINE CENTER DR SUITE 200 SE DECISION MADE: 23-AUG-12 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ETCHONIA ZERONA ARMS ERCHONIA CORPORATION 510(k) NO: K121690(TRADITIONAL) ATTN: KEVIN WALLS PHONE NO : 720 962 5412 5401 S. COTTONWOOD CT. SE DECISION MADE: 23-AUG-12 GREENWOOD VILLAGE CO 80121 510(k) STATEMENT DEVICE: TRANS1 INTERBODY FUSION SYSTEM TRANS1 INCORPORATED 510(k) NO: K120991(TRADITIONAL) ATTN: CHERYL L WAGONER PHONE NO : 910 332 1700 301 Government Center Dr Suite 100SE DECISION MADE: 23-AUG-12 WILMINGTON NC 28403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NMI PICC III NAVILYST MEDICAL, INC. 510(k) NO: K121089(TRADITIONAL) ATTN: LORRAINE M HANLEY PHONE NO : 508 658 7945 26 FOREST STREET SE DECISION MADE: 23-AUG-12 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ERCHONIA ZERONA ERCHONIA CORPORATION 510(k) NO: K121695(TRADITIONAL) ATTN: KEVIN WALLS PHONE NO : 720 962 5412 5401 S. COTTONWOOD CT. SE DECISION MADE: 23-AUG-12 GREENWOOD VILLAGE CO 80121 510(k) STATEMENT DEVICE: AVT NATURASOFT ADVANCED VISION TECHNOLOGIES 510(k) NO: K121324(TRADITIONAL) ATTN: MARTIN DALSING PHONE NO : 970 243 5490 806 KIMBALL AVE SE DECISION MADE: 23-AUG-12 GRAND JUNCTION CO 81501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLARCUP DUAL MOBILITY SYSTEM SMITH & NEPHEW, INC. 510(k) NO: K122244(SPECIAL) ATTN: JOHN CONNOR PHONE NO : 901 399 5944 1450 BROOKS RD. SE DECISION MADE: 23-AUG-12 MEMPHIS TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES CURVILINEAR DISTRACTION SYSTEM SYNTHES INC 510(k) NO: K121502(TRADITIONAL) ATTN: ALAN T HALEY PHONE NO : 484 356 9763 1301 GOSHEN PARKWAY SE DECISION MADE: 23-AUG-12 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALGINOR ALGINELLE TYPE 1 AND 2 MILLENIUM KROMOPAN 1 AND 2 LASCOD SPA 510(k) NO: K121824(TRADITIONAL) ATTN: BLIX WINSTON PHONE NO : 301 607 9185 2600 MULLININIX MILL ROAD SE DECISION MADE: 23-AUG-12 MT. AIRY MD 21771 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: (MULTIPLE) DIGITAL THERMOMETER CHINA SHENYANG MED-LAND IMP/EXP CO510(k) NO: K120004(TRADITIONAL) ATTN: ANN D MCGONIGLE PHONE NO : 508 358 9114 19 SEDGEMEADOW RD SE DECISION MADE: 23-AUG-12 WAYLAND MA 01778 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMPLATZER TORQVUE FX AGA MEDICAL CORPORATION 510(k) NO: K121611(TRADITIONAL) ATTN: SHERRY KOLLMANN PHONE NO : 651 756 5463 5050 NATHAN LANE SE DECISION MADE: 23-AUG-12 PLYMOUTH MN 55433 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THERMAL LIGATING SHEARS MICROLINE SURGICAL, INC 510(k) NO: K122086(TRADITIONAL) ATTN: WILLIAM MCCALLUM PHONE NO : 978 967 1726 800 CUMMING CENTER SUITE 166T SE DECISION MADE: 23-AUG-12 BEVERLY MA 01915 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARJORAD STERILE WRAP ARJO WIGGINS MEDICAL, INC. 510(k) NO: K110954(TRADITIONAL) ATTN: JON WARD PHONE NO : 813 645 2855 962 ALLEGRO LANE SE DECISION MADE: 24-AUG-12 APOLLO BEACH FL 33572 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RANDOX OPIATES ASSAY RANDOX LABORATORIES LIMITED 510(k) NO: K113747(TRADITIONAL) ATTN: PAULINE ARMSTRONG PHONE NO : 440 289 4422413 55 DIAMOND ROAD SE DECISION MADE: 24-AUG-12 CRUMLIN UK BT29 4QY 510(k) STATEMENT DEVICE: ELEVANCE MIDMARK 510(k) NO: K120239(SPECIAL) ATTN: ROBYN SCOPIS PHONE NO : 949 422 3853 1801 EDGECLIFF DRIVE SE DECISION MADE: 24-AUG-12 FULLERTON CA 92831 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT GRIFOLS USA, LLC 510(k) NO: K120169(TRADITIONAL) ATTN: GARY LEHNUS PHONE NO : 570 620 0198 482 CHERRY LANE RD. SE DECISION MADE: 24-AUG-12 EAST STROUDSBURG PA 18301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIMMER TRABECULAR METAL TOTAL ANKLE ZIMMER, INC. 510(k) NO: K120906(TRADITIONAL) ATTN: REBECCA DILL PHONE NO : 574 372 4260 P.O. BOX 708 SE DECISION MADE: 24-AUG-12 WARSAW IN 46581 0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR SORIN GROUP ITALIA S.R.L. 510(k) NO: K122254(SPECIAL) ATTN: SCOTT LIGHT PHONE NO : 303 467 6313 14401 W. 65TH WAY SE DECISION MADE: 24-AUG-12 ARVADA CO 80004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LDR SPINE USA SPINE TUNE, TL SPINAL SYSTEM, LDR SPINE USA EASYSPINE, POSTERIOR SPINAL SYSTEM, LDR SPINE USA MC IMPLANT S LDR SPINE USA INC. 510(k) NO: K121103(TRADITIONAL) ATTN: BRADLEY W STRASSER PHONE NO : 512 344 3395 13785 RESEARCH BOULEVARD SUITE 200SE DECISION MADE: 24-AUG-12 AUSTIN TX 78750 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUVASIVE POLYAXIAL SPINAL SCREWS NUVASIVE, INC. 510(k) NO: K121619(SPECIAL) ATTN: ELIAS KETCHUM PHONE NO : 858 320 4588 7475 LUSK BLVD SE DECISION MADE: 24-AUG-12 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AIXPLORER SUPERSONIC IMAGINE 510(k) NO: K121329(TRADITIONAL) ATTN: JACQUES SOUQUET PHONE NO : 334 429 92424 510 RUE RENE DESCARTES SE DECISION MADE: 24-AUG-12 AIX-EN-PROVENCE FR 13857 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHANTOM PLUS CERAMIC CAGE SYSTEM AMEDICA CORP. 510(k) NO: K121892(SPECIAL) ATTN: ROBERT M WOLFARTH PHONE NO : 801 583 5100 615 ARAPEEN DRIVE SE DECISION MADE: 24-AUG-12 SALT LAKE CITY UT 84108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INWAVE ZYNEX MEDICAL, INC. 510(k) NO: K121820(ABBREVIATED) ATTN: JIM ARNOLD PHONE NO : 303 703 4906 9990 Park Meadows Dr. SE DECISION MADE: 24-AUG-12 Lone Tree CO 80124 510(k) STATEMENT DEVICE: ELECSYS HSV-2 IGG IMMUNOASSAY ROCHE DIAGNOSTICS 510(k) NO: K121895(TRADITIONAL) ATTN: K. COLLEEN ADAMS PHONE NO : 317 521 3577 9115 HAGUE ROAD SE DECISION MADE: 24-AUG-12 INDIANAPOLIS IN 46250 0416 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PICIS WEIGHT BASED DOSE CONVERTER PICIS INC. 510(k) NO: K121542(TRADITIONAL) ATTN: JANICE HOGAN PHONE NO : 267 675 4600 1835 MARKET ST, 29TH FLOOR SE DECISION MADE: 27-AUG-12 PHILADELPHIA PA 19103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BAROSTAT SOFTWARE OPTION CROSPON, LTD. 510(k) NO: K120997(TRADITIONAL) ATTN: PAUL DRYDEN PHONE NO : 239 498 2155 24301 WOODSAGE DRIVE SE DECISION MADE: 27-AUG-12 BONITA SPRINGS FL 34134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRITON ELECTRIC HIGH TORQUE HANDPIECE AND SOFTWARE MODULE MEDTRONIC SURGICAL TECHNOLOGIES 510(k) NO: K121264(TRADITIONAL) ATTN: RISHI SINHA PHONE NO : 817 788 6685 4620 NORTH BEACH STREET SE DECISION MADE: 27-AUG-12 FORT WORTH TX 76137 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACE MAGNESIUM REGENT ALFA WASSERMANN DIAGNOSTICS TECHNO510(k) NO: K122302(SPECIAL) ATTN: HYMAN KATZ PHONE NO : 973 852 0158 4 HENDERSON DRIVE SE DECISION MADE: 27-AUG-12 WEST CALDWELL NJ 07006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XIA 3 SPINAL SYSTEM STRYKER SPINE 510(k) NO: K113666(TRADITIONAL) ATTN: G. STIEGMAN PHONE NO : 202 552 5800 1331 H STREET NW 12TH FLOOR SE DECISION MADE: 28-AUG-12 WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM (USING CARESTREAM CR MAMMOGRAPHY CASSETTE WITH SNP-M1 SCREEN) CARESTREAM HEALTH,INC. 510(k) NO: K120246(TRADITIONAL) ATTN: KATHERINE HONSINGER PHONE NO : 585 627 6491 150 VERONA STREET SE DECISION MADE: 28-AUG-12 ROCHESTER NY 14608 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AIXPLORER SUPERSONIC IMAGINE 510(k) NO: K112255(TRADITIONAL) ATTN: JACQUES SOUQUET PHONE NO : 011 334 42992435 510. RUE RENE DESCARTES BAT. E ET SE DECISION MADE: 28-AUG-12 AIX EN PROVENCE FR 13857 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PMMA CAD/CAM DISC POLIDENT D.O.O., DENTAL PRODUCTS I510(k) NO: K112967(TRADITIONAL) ATTN: JANJA LIPUSCEK PHONE NO : 386 5 3304859 VOLCJA DRAGA 42 SE DECISION MADE: 28-AUG-12 VOLCJA DRAGA SI 5293 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITEK 2 STRPTOCOCCUS CEFTRIAXONE BIOMERIEUX, INC. 510(k) NO: K122359(TRADITIONAL) ATTN: THI MY LAN DANG PHONE NO : 314 731 8799 595 ANGLUM RD. SE DECISION MADE: 28-AUG-12 HAZELWOOD MO 63042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FDR GO FLEX FUJIFILM MEDICAL SYSTEM U.S.A., IN510(k) NO: K120629(SPECIAL) ATTN: PETER ALTMAN PHONE NO : 203 602 3576 419 WEST AVE. SE DECISION MADE: 28-AUG-12 STAMFORD CT 06902 6300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CATALYS PRECISION LASER SYSTEM OPTIMEDICA CORPORATION 510(k) NO: K121091(TRADITIONAL) ATTN: ALAN MARQUARDT PHONE NO : 408 792 8173 1310 MOFFETT PARK DRIVE SE DECISION MADE: 28-AUG-12 SUNNYVALE CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER ARROW INTERNATIONAL, INC. 510(k) NO: K122027(TRADITIONAL) ATTN: PAUL AMUDALA PHONE NO : 610 378 0131 2400 BERNVILLE RD. SE DECISION MADE: 28-AUG-12 READING PA 19605 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LARYNGEAL ELECTRODE TECHNOMED EUROPE 510(k) NO: K121257(TRADITIONAL) ATTN: PIERRE VREULS PHONE NO : 314 340 86868 AMERIKALAAN 71 SE DECISION MADE: 28-AUG-12 MAASTRICHT AIRPORT NL 6199 AE 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENLUXTRA HUMIFIBER WOUND DRESSING BASF VENTURE CAPITAL AMERICA INC. 510(k) NO: K122297(TRADITIONAL) ATTN: NADI ERGENC, PH.D. PHONE NO : 914 785 4362 100 CAMPUS DRIVE SE DECISION MADE: 28-AUG-12 FLORAM PARK NJ 07932 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PAX-UNI3D, PHT-7500 VATECH CO., LTD. 510(k) NO: K121400(SPECIAL) ATTN: DAVE KIM PHONE NO : 713 467 2607 12946 KIMBERLEY LN SE DECISION MADE: 28-AUG-12 HOUSTON TX 77079 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SL-PLUS MIA FEMORAL STEMS WITH TI/HA COATING SMITH & NEPHEW, INC. 510(k) NO: K122296(SPECIAL) ATTN: JOHN CONNOR PHONE NO : 901 399 5944 1450 BROOKS RD. SE DECISION MADE: 28-AUG-12 MEMPHIS TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ICEROD CX CRYOABLATION NEEDLE ICEROD CX CRYOABLATION NEEDLE MULTIPACK GALIL MEDICAL LTD. 510(k) NO: K121251(TRADITIONAL) ATTN: LYNNE DAVIES PHONE NO : 651 287 5098 126 MESQUITE STREET SE DECISION MADE: 28-AUG-12 LAKE JACKSON TX 77566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TERUMO SURGUARD3 SAFETY NEEDLE & HYPODERMIC SYRINGE WITH SAFETY NEEDLE TERUMO (PHILIPPINES) CORPORATION 510(k) NO: K122249(SPECIAL) ATTN: PHILLIP LESTER PHONE NO : 410 392 7321 950 ELKTON BLVD SE DECISION MADE: 28-AUG-12 ELKTON MD 21921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERY THEKEN SPINE LLC 510(k) NO: K121482(TRADITIONAL) ATTN: DALE DAVISON PHONE NO : 330 239 7709 1153 MEDINA RD. SE DECISION MADE: 28-AUG-12 MEDINA OH 44256 0000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTHERA SYSTEM ULTHERA, INC. 510(k) NO: K122528(TRADITIONAL) ATTN: SUZON LOMMEL PHONE NO : 480 619 4069 2150 South Country Club Drive SuitSE DECISION MADE: 28-AUG-12 Mesa AZ 85210 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K122323(TRADITIONAL) ATTN: ROSE T MARINELLI PHONE NO : 302 631 8805 500 GBC DRIVE MS 514 SE DECISION MADE: 28-AUG-12 NEWARK DE 19702 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IPS EMPRESS DIRECT COLOR IPS EMPRESS DIRECT OPAQUE IVOCLAR VIVADENT AG 510(k) NO: K121230(TRADITIONAL) ATTN: SANDRA CAKEBREAD PHONE NO : 423 235 3535 BENDERERSTRASSE 2 SE DECISION MADE: 29-AUG-12 SCHAAN LS FL-9494 510(k) STATEMENT DEVICE: STAXX XD SYSTEM SPINE WAVE, INC. 510(k) NO: K121889(SPECIAL) ATTN: ROAIDA RIZKALLAH PHONE NO : 203 944 9494 THREE ENTERPRISE DR. SUITE 210 SE DECISION MADE: 29-AUG-12 SHELTON CT 06484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAPSTONE SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K121760(TRADITIONAL) ATTN: BRAD SHEALS PHONE NO : 901 396 3133 1800 PYRAMID PLACE SE DECISION MADE: 29-AUG-12 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TOMOTHERAPY TREATMENT SYSTEM ACCURAY INCORPORATED 510(k) NO: K121934(TRADITIONAL) ATTN: GREG BANGE PHONE NO : 608 830 3605 1209 DEMING WAY SE DECISION MADE: 29-AUG-12 MADISON WI 53717 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEURO VENTION LAMINPLASTY PLATING SYSTEM NEUROVENTION LLC 510(k) NO: K121276(TRADITIONAL) ATTN: MEREDITH MAY PHONE NO : 719 337 7579 4628 NORTHPARK DRIVE SE DECISION MADE: 29-AUG-12 MEREDITH MAY CO 80918 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SINUS DILATION SYSTEM ENTRIGUE SURGICAL, INC. 510(k) NO: K121351(TRADITIONAL) ATTN: GABRIELE G NIEDERAUER, PH.D.PHONE NO : 210 298 6336 12672 SILICON DR. STE 150 SE DECISION MADE: 29-AUG-12 SAN ANTONIO TX 78249 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEM-7200-Z (BP742) OMRON HEALTHCARE, INC. 510(k) NO: K121932(TRADITIONAL) ATTN: PAUL DRYDEN PHONE NO : 239 498 2155 24301 WOODSAGE DRIVE SE DECISION MADE: 29-AUG-12 BONITA SPRINGS FL 34134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INFILL GRAFT DELIVERY SYSTEM PINNACLE SPINE GROUP, LLC 510(k) NO: K121476(SPECIAL) ATTN: REBECCA K PINE PHONE NO : 760 809 5178 1601 Elm St Ste 300 SE DECISION MADE: 29-AUG-12 Dallas TX 75201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PADNET 2.0 BIOMEDIX, INC. 510(k) NO: K122281(SPECIAL) ATTN: GREG HOCKING PHONE NO : 651 762 4010 178 East 9th Street SE DECISION MADE: 29-AUG-12 ST. PAUL MN 55101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP ATRICURE, INC. 510(k) NO: K122276(SPECIAL) ATTN: JAMES LUCKY PHONE NO : 513 755 5754 6217 CENTRE PARK DRIVE SE DECISION MADE: 29-AUG-12 WEST CHESTER OH 45069 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTELLIVUE PATIENT MONITOR PHILIPS MEDIZIN SYSTEME BOEBLINGEN510(k) NO: K122439(SPECIAL) ATTN: HERBERT VAN DYK PHONE NO : 497 031 4631734 HEWLETT-PACKARD STR. 2 SE DECISION MADE: 29-AUG-12 BOEBLINGEN GM 71034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AZUR DETACHABLE 35 MICROVENTION, INC. 510(k) NO: K122316(SPECIAL) ATTN: CYNTHIA VALENZUELA PHONE NO : 714 247 8000 1311 VALENCIA AVE SE DECISION MADE: 29-AUG-12 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TETRIS II SIGNUS MEDIZINTECHNIK GMBH 510(k) NO: K122317(SPECIAL) ATTN: KAREN E WARDEN PHONE NO : 440 729 8457 PO BOX 566 SE DECISION MADE: 29-AUG-12 CHESTERLAND OH 44026 2141 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTRODUCER SET, MODEL ADELANTE-S SERIES OSCOR INC. 510(k) NO: K122084(SPECIAL) ATTN: MILA DOSKOCIL PHONE NO : 727 937 2511 3816 DE SOTO BLVD. SE DECISION MADE: 29-AUG-12 PALM HARBOR FL 34683 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTISAN EXTEND CONTROL CATHETER HANSEN MEDICAL 510(k) NO: K122275(SPECIAL) ATTN: HASSAN LABAY PHONE NO : 860 404 5800 800 EAST MIDDLEFIELD ROAD SE DECISION MADE: 29-AUG-12 MOUNTAIN VIEW CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIMMER DENTAL TAPERED SCREW-VENT X ZIMMER DENTAL INC. 510(k) NO: K113753(TRADITIONAL) ATTN: MELISSA BURBAGE PHONE NO : 760 929 4300 1900 ASTON AVE. SE DECISION MADE: 30-AUG-12 CARLSBAD CA 92008 7308 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LOQTEQ SMALL FRAGMENT SET LOQTEQ CORTICAL SCREW3.5, SMALL HEAD, T15, SELF TAPPING LOQTEQ CORTICAL SCREW 3.5, T15, SELF T AAP IMPLANTATE AG 510(k) NO: K113652(TRADITIONAL) ATTN: MARC SEEGERS PHONE NO : 493 075 019192 LORENZWEG 5 SE DECISION MADE: 30-AUG-12 BERLIN GM 12099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VANTERA CHINIAL ANALYZER LIPOSCIENCE 510(k) NO: K113830(TRADITIONAL) ATTN: SUZETTE WARNER PHONE NO : 919 256 1326 2500 SUMMER BLVD. SE DECISION MADE: 30-AUG-12 RALEIGH NC 27616 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIMEX NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMPS SERIES: SIM-EX200 AND SIM-EX300 SIMEX MEDIZINTECHNIK GMBH 510(k) NO: K113291(TRADITIONAL) ATTN: HAMID KHOSROWSHAHI PHONE NO : 914 772 7326 P.O. BOX 1207 SE DECISION MADE: 30-AUG-12 DEISSLINGEN GM D-78649 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRECISE SHP DIODE LASER CAO GROUP, INC. 510(k) NO: K113472(TRADITIONAL) ATTN: ROB K LARSEN PHONE NO : 801 256 9282 4628 WEST SKYHAWK DRIVE SE DECISION MADE: 30-AUG-12 WEST JORDAN UT 84084 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROTURA COUCH SOFTWARE MED-TEC, INC. D/B/A CIVCO MEDICAL 510(k) NO: K122201(TRADITIONAL) ATTN: AMANDA STAHLE PHONE NO : 319 248 6628 1401 8TH STREET SE SE DECISION MADE: 30-AUG-12 ORANGE CITY IA 51041 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMARTLYTE ELECTROLYTE ANALYZER DIAMOND DIAGNOSTICS, INC. 510(k) NO: K121040(TRADITIONAL) ATTN: KATHY CRUZ PHONE NO : 508 429 0450 333 FISKE ST. SE DECISION MADE: 30-AUG-12 HOLLISTON MA 01746 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DTAD GYRUS ACMI, INC. 510(k) NO: K121678(TRADITIONAL) ATTN: DOLAN MILLS PHONE NO : 901 373 0236 136 TURNPIKE RD. SE DECISION MADE: 30-AUG-12 SOUTHBOROUGH MA 01772 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUS THE BINDING SITE GROUP LTD 510(k) NO: K122066(SPECIAL) ATTN: JILL CONSTANTINE PHONE NO : 440 121 4569500 8 CALTHORPE ROAD EDGBASTON SE DECISION MADE: 30-AUG-12 BIRMINGHAM, WEST MIDLANDS UK B1510(k) STATEMENT DEVICE: THIXO-GEL ULTRASOUND SPRAY CLOVERLINE INTERNATIONAL PHARMA SE510(k) NO: K121311(TRADITIONAL) ATTN: CHRISTINA BERNSTEIN PHONE NO : 415 450 0515 2670 LEAVENWORTH STREET SE DECISION MADE: 30-AUG-12 SAN FRANCISCO CA 94133 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RUBICON 18 SUPPORT CATHETER BOSTON SCIENTIFIC CORP. 510(k) NO: K122394(SPECIAL) ATTN: DIANE NELSON PHONE NO : 763 255 0813 ONE SCIMED PLACE SE DECISION MADE: 30-AUG-12 MAPLE GROVE MN 55311 1566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CERVICAL CAGE EISERTECH, LLC 510(k) NO: K122444(SPECIAL) ATTN: LUKAS EISERMANN PHONE NO : 888 262 2817 1133 COLUMBIA STREET SUITE 107 SE DECISION MADE: 30-AUG-12 SAN DIEGO CA 92101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRAINFIX 2 TITANIUM CLAMP SYSTEM AESCULAP, INC. 510(k) NO: K122353(SPECIAL) ATTN: DENISE ADAMS PHONE NO : 610 984 9076 3773 CORPORATE PARKWAY SE DECISION MADE: 30-AUG-12 CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DACRYOCATH ARMADILLO BIOMEDICAL, LLC 510(k) NO: K113508(TRADITIONAL) ATTN: ROBYN SCOPIS PHONE NO : 949 262 0411 3722 AVE SAUSALITO SE DECISION MADE: 31-AUG-12 IRVINE CA 92606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PINTLER PATIENT WARMING SYSTEM PINTLER MEDICAL 510(k) NO: K113705(TRADITIONAL) ATTN: MARIBETH MACINTYRE-ELLIS PHONE NO : 206 660 9020 3220 S. HANFORD STREET SE DECISION MADE: 31-AUG-12 SEATTLE WA 98144 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: TYSHAK NUCLEUS NUMED, INC. 510(k) NO: K121859(SPECIAL) ATTN: NICHELLE LAFLESH PHONE NO : 315 328 4491 2880 MAIN ST. SE DECISION MADE: 31-AUG-12 HOPKINTON NY 12965 510(k) STATEMENT DEVICE: FLEXLAB 3.6, ACCELERATOR A3600 INPECO S.P.A. 510(k) NO: K121012(TRADITIONAL) ATTN: ROBERTO TAMBORRA PHONE NO : 39 02 36681263 11 VIA G. DI VITTORIO SE DECISION MADE: 31-AUG-12 SEGRATE, MILAN IT 20090 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STALIF C CENTINEL SPINE, INC. 510(k) NO: K120819(SPECIAL) ATTN: JOHN PARRY PHONE NO : 484 887 8813 900 AIRPORT RD, STE #3B SE DECISION MADE: 31-AUG-12 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE) BOSTON SCIENTIFIC CORP. 510(k) NO: K121196(TRADITIONAL) ATTN: VICKY L HAGENS PHONE NO : 763 255 0303 ONE SCIMED PLACE SE DECISION MADE: 31-AUG-12 MAPLE GROVE MN 55311 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOSABLE HEMOSTASIS CHIP WILSON-COOK MEDICAL, INC. / COOK E510(k) NO: K121505(TRADITIONAL) ATTN: SCOTTIE FARIOLE PHONE NO : 336 744 0157 4900 BETHANIA STATION ROAD SE DECISION MADE: 31-AUG-12 WINSTON-SALEM NC 27105 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THERMO SCIENTIFIC MAS OMNI-CARDIO MICROGENICS CORPORATION 510(k) NO: K122291(TRADITIONAL) ATTN: KAREN LEE PHONE NO : 510 979 5000 46360 FREMONT BLVD SE DECISION MADE: 31-AUG-12 FREMONT CA 94538 6406 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 257 TOTAL WITH SUMMARIES 240 TOTAL WITH STATEMENTS 17
-
-
