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U.S. Department of Health and Human Services

Medical Devices

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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