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SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE) 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD 01-DEC-2005 THROUGH 31-DEC-2005 DEVICE: BEAMER PAINLOW INFRARED LIGHT TREATMENT SYSTEM BEAMLINE CORPORATION 510(k) NO: K052307(TRADITIONAL) ATTN: DAVID R BALZER PHONE NO : 203-558-4889 602 ANACAPA SE DECISION MADE: 16-DEC-05 IRVINE, CA 92602 510(k) STATEMENT DEVICE: 3M TEGADERM SILVER (AG) MESH 3M COMPANY 510(k) NO: K053256(SPECIAL) ATTN: AMY E SHORT PHONE NO : 651-737-6707 3M CENTER, BLDG. 275-5W-06 SE DECISION MADE: 16-DEC-05 ST. PAUL, MN 55133-3275 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSULIN PUMP ABBOTT DIABETES CARE INC. 510(k) NO: K051041(TRADITIONAL) ATTN: MARY ROSE PHONE NO : 510-239-2634 1360 SOUTH LOOP RD. SE DECISION MADE: 23-DEC-05 ALAMEDA, CA 94502-7000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARCHITECT B12 CALIBRATORS ABBOTT LABORATORIES 510(k) NO: K053330(SPECIAL) ATTN: MARGARET PROCHNIAK PHONE NO : 847-937-4106 100 ABBOTT PARK RD. SE DECISION MADE: 16-DEC-05 ABBOTT PARK, IL 60064-6095 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: C2000 AUTOMATED MANIFOLD KIT ACIST MEDICAL SYSTEMS, INC. 510(k) NO: K052744(SPECIAL) ATTN: A; SAALABI PHONE NO : 952-995-9360 7450 FLYING CLOUD DR. SE DECISION MADE: 16-DEC-05 SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA EDEN PRAIRIE, MN 55344 DEVICE: ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT ADVANCED NEUROMODULATION SYSTEMS 510(k) NO: K053250(SPECIAL) ATTN: DANIELLE ALARCON PHONE NO : 972-309-8559 6901 PRESTON RD. SE DECISION MADE: 15-DEC-05 PLANO, TX 75024 510(k) STATEMENT DEVICE: BREATHING FILTER BACTERIAL/VIRAL, MODEL AG7178 AG INDUSTRIES 510(k) NO: K052087(TRADITIONAL) ATTN: IAN GORDON PHONE NO : 727-797-4727 2454 MCMULLEN BOOTH ROAD SE DECISION MADE: 14-DEC-05 SUITE 427 510(k) SUMMARY AVAILABLE FROM FDA CLEARWATER, FL 33759 DEVICE: AMPLATZER SIZING BALLOON II AGA MEDICAL CORP. 510(k) NO: K053440(SPECIAL) ATTN: AMANDA JOHNSON PHONE NO : 888-546-4407 682 MENDELSSOHN AVE. SE DECISION MADE: 30-DEC-05 GOLDEN VALLEY, MN 55427 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WEB1000 AGFA CORP. 510(k) NO: K053458(TRADITIONAL) ATTN: PHIL CUSCUNA PHONE NO : 519-746-2900 455 PHILIP STREET SE DECISION MADE: 22-DEC-05 WATERLOO, ONTARIO, CANADA N2L 3X2 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CADIMAS VERSION 1.0 ALAN PENN & ASSOCIATES., INC. 510(k) NO: K052023(TRADITIONAL) ATTN: ROGER H SCHNEIDER PHONE NO : 301-229-8442 6319 MASSACHUSETTS AVENUE SE DECISION MADE: 08-DEC-05 BETHESDA, MD 20816-1139 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERIFY FLASH INTEGRATOR ALBERT BROWNE LTD. 510(k) NO: K051101(TRADITIONAL) ATTN: CYNTHIA J M. NOLTE PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 06-DEC-05 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DU857 DUAL FREQUENCY ULTRASOUND THERAPY AND MUSCLE STIMULATOR S ALFA TECH MEDICAL SYSTEMS, LTD. 510(k) NO: K052340(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502 55 NORTHERN BLVD., STE 200 SE DECISION MADE: 09-DEC-05 GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LAGUNA MONOAXIAL PEDICLE SCREW SYSTEM ALLEZ SPINE, LLC 510(k) NO: K051275(SPECIAL) ATTN: HARTMUT LOCH PHONE NO : 619-885-7733 2009 FREDA LANE SE DECISION MADE: 09-DEC-05 CARDIFF, CA 92007 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALMITECH INC. DENTAL IMPLANT SYSTEM ALMITECH INC. 510(k) NO: K052733(TRADITIONAL) ATTN: ALEX BREYTMAN PHONE NO : 516-343-3050 2643 BEDELL ST. SE DECISION MADE: 22-DEC-05 BELLMORE, NY 11710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMBU MARK IV RESUSCITATOR AMBU A/S 510(k) NO: K053140(TRADITIONAL) ATTN: SANJAY PARIKH PHONE NO : 410-768-6464 6740 BAYMEADOW DR. SE DECISION MADE: 23-DEC-05 GLEN BURNIE, MD 21060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMBU MARK IV BABY RESUSCITATOR AMBU A/S 510(k) NO: K053142(TRADITIONAL) ATTN: SANJAY PARIKH PHONE NO : 410-768-6464 6740 BAYMEADOW DR. SE DECISION MADE: 20-DEC-05 GLEN BURNIE, MD 21060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMEDITECH DRUGSMARTCUP AMEDITECH, INC. 510(k) NO: K053175(SPECIAL) ATTN: JOHN WU PHONE NO : 858-535-1968 10340 CAMINO SANTA FE, SUITE F SE DECISION MADE: 08-DEC-05 SAN DIEGO, CA 92121 510(k) STATEMENT DEVICE: FETALGARD LITE-NIBP, MODEL FGL-NIBP ANALOGIC CORPORATION 510(k) NO: K051903(TRADITIONAL) ATTN: JANET KWIATKOWSKI PHONE NO : 978-326-4186 8 CENTENNIAL DR. SE DECISION MADE: 27-DEC-05 PEABODY, MA 01960 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISTAL RADIO-ULNAR JOINT IMPLANT APTIS MEDICAL, LLC. 510(k) NO: K053119(SPECIAL) ATTN: BRYAN BABB PHONE NO : 502-899-3974 5 RIVER HILL RD. SE DECISION MADE: 07-DEC-05 LOUISVILLE, KY 40207 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TIGHTROPE ACROMIOCLAVICULAR (AC) DEVICE, TITANIUM, STAINLESS STE ARTHREX, INC. 510(k) NO: K052776(TRADITIONAL) ATTN: SALLY FOUST PHONE NO : 239-643-5553 1370 CREEKSIDE BLVD. SE DECISION MADE: 13-DEC-05 NAPLES, FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTHREX TENSIONLOK ARTHREX, INC. 510(k) NO: K052901(SPECIAL) ATTN: ANN WATERHOUSE PHONE NO : 239-643-5553 1370 CREEKSIDE BLVD. SE DECISION MADE: 12-DEC-05 NAPLES, FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTHROCARE 8000S COBLATOR SURGERY SYSTEM ARTHROCARE CORP. 510(k) NO: K053297(SPECIAL) ATTN: VALERIE DEFIESTA-NG PHONE NO : 408-736-0224 680 VAQUEROS AVE. SE DECISION MADE: 06-DEC-05 SUNNYVALE, CA 94085-3523 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTHROCARE PERC-D SPINEWAND ARTHROCARE CORP. 510(k) NO: K053447(SPECIAL) ATTN: VALERIE DEFIESTA-NG PHONE NO : 408-736-0224 680 VAQUEROS AVE. SE DECISION MADE: 27-DEC-05 SUNNYVALE, CA 94085-3523 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: B-CARE POWDERED LATEX EXAMINATION GLOVES B-CARE INDUSTRIES CO., LTD. 510(k) NO: K052845(TRADITIONAL) ATTN: KEVIN WALLS PHONE NO : 720-962-5412 13 RED FOX LANE SE DECISION MADE: 16-DEC-05 LITTLETON, CO 80127 510(k) STATEMENT DEVICE: BARRIERPLUS GOLD ORTHO POWDER-FREE SYNTHETIC POLYISOPRENE ORTHOP BARRIERMED GLOVE CO. 510(k) NO: K052772(TRADITIONAL) ATTN: VICTOR J RAGUCCI PHONE NO : 407-771-4424 155 TECHNOLOGY PARK SE DECISION MADE: 20-DEC-05 LAKE MARY, FL 32746 510(k) STATEMENT DEVICE: MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSL BAYER HEALTHCARE, LLC 510(k) NO: K051693(TRADITIONAL) ATTN: ANDREA HOLLE PHONE NO : 914-524-3494 511 BENEDICT AVE. SE DECISION MADE: 07-DEC-05 TARRYTOWN, NY 10591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM BAYER HEALTHCARE, LLC 510(k) NO: K052503(TRADITIONAL) ATTN: ANDRES HOLLE PHONE NO : 914-524-3494 511 BENEDICT AVE. SE DECISION MADE: 14-DEC-05 TARRYTOWN, NY 10591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM BAYER HEALTHCARE, LLC 510(k) NO: K053020(TRADITIONAL) ATTN: ANDRES HOLLE PHONE NO : 914-524-3494 511 BENEDICT AVE. SE DECISION MADE: 30-DEC-05 TARRYTOWN, NY 10591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN BECKMAN COULTER, INC. 510(k) NO: K053090(TRADITIONAL) ATTN: ERI HIRUMI PHONE NO : 714-961-4389 200 SOUTH KRAEMER BLVD. W-110 SE DECISION MADE: 16-DEC-05 BREA, CA 92822 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOXITIN GP 1-32 G/M BECTON, DICKINSON & CO. 510(k) NO: K053241(TRADITIONAL) ATTN: MONICA E GIGUERE PHONE NO : 410-316-4287 7 LOVETON CIR. SE DECISION MADE: 22-DEC-05 SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20 BIO PROTECH, INC. 510(k) NO: K053011(TRADITIONAL) ATTN: E.J. SMITH PHONE NO : 888-729-9674 1676 VILLAGE GREEN SUITE A SE DECISION MADE: 14-DEC-05 CROFTON, MD 21114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOHORIZONS SINGLE-STAGE IMPLANT BIOHORIZONS IMPLANT SYSTEMS, INC. 510(k) NO: K053152(SPECIAL) ATTN: WINSTON GREER PHONE NO : 205-967-7880 ONE PERIMETER PARK SOUTH SE DECISION MADE: 02-DEC-05 SUITE 230, SOUTH 510(k) SUMMARY AVAILABLE FROM FDA BIRMINGHAM, AL 35243 DEVICE: COAG-A-MATE MTX III BIOMERIEUX, INC. 510(k) NO: K051030(TRADITIONAL) ATTN: JOHN CUSACK PHONE NO : 919-620-2000 100 RODOLPHE ST SE DECISION MADE: 23-DEC-05 DURHAM, NC 27712 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITEK 2 GRAM POSITIVE CEFOXITIN SCREEN BIOMERIEUX, INC. 510(k) NO: K053097(TRADITIONAL) ATTN: NANCY WEAVER PHONE NO : 314-731-8695 595 ANGLUM RD. SE DECISION MADE: 14-DEC-05 HAZELWOOD, MO 63042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITEK 2 GRAM POSITIVE TELITHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE BIOMERIEUX, INC. 510(k) NO: K053186(TRADITIONAL) ATTN: NANCY WEAVER PHONE NO : 314-731-8695 595 ANGLUM RD. SE DECISION MADE: 01-DEC-05 HAZELWOOD, MO 63042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POROUS TITANIUM ACETABULAR AUGMENTS BIOMET MANUFACTURING CORP. 510(k) NO: K052888(TRADITIONAL) ATTN: ALLISON KOSKEY PHONE NO : 574-372-1644 56 EAST BELL DRIVE PO BX 587 SE DECISION MADE: 06-DEC-05 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STAGEONE DISPOSABLE CEMENT SPACER MOLD FOR TEMPORARY HIP PROSTHE BIOMET, INC. 510(k) NO: K052990(TRADITIONAL) ATTN: LESTER F PADILLA PHONE NO : 574-267-6639 56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 16-DEC-05 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FC 700 FETAL MONITOR BIONET CO., LTD. 510(k) NO: K043597(TRADITIONAL) ATTN: SUN-YOUNG JEONG PHONE NO : 82 33 7602852 MEDICAL INDUSTRY TECHNO TOWER SE DECISION MADE: 16-DEC-05 R205, 1272 MAEJI HEUNGUP 510(k) SUMMARY AVAILABLE FROM FDA WONJU, KWANGWON-DO, REPUBLIC OF KOREA DEVICE: FC 1400 FETAL MONITOR BIONET CO., LTD. 510(k) NO: K043598(TRADITIONAL) ATTN: SUN-YOUNG JEONG PHONE NO : 82 33 7602852 MEDICAL INDUSTRY TECHNO TOWER SE DECISION MADE: 16-DEC-05 R205, 1272 MAEJI HEUNGUP 510(k) SUMMARY AVAILABLE FROM FDA WONJU, KWANGWON-DO, REPUBLIC OF KOREA DEVICE: BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000 BIONICARE MEDICAL TECHNOLOGIES, IN510(k) NO: K052625(TRADITIONAL) ATTN: KENT HOFFMAN PHONE NO : 410-472-1888 47 R LOVETON CIRCLE SE DECISION MADE: 05-DEC-05 SPARKS, MD 21152 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOSPACE BODY COMPOSITION ANALYZERS, MODELS INBODY 520, 720 AND BIOSPACE CORPORATION LIMITED 510(k) NO: K052646(SPECIAL) ATTN: DANIEL KAMM PHONE NO : 847-374-1727 PO BOX 7007 SE DECISION MADE: 16-DEC-05 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICE BIOWAVE CORPORATION 510(k) NO: K052289(TRADITIONAL) ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 13-DEC-05 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER BIPORE, INC. 510(k) NO: K051513(ABBREVIATED) ATTN: KEITH PALUCH PHONE NO : 201-767-1993 31 INDUSTRIAL PKWY. SE DECISION MADE: 07-DEC-05 NORTHVALE, NJ 07647 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MULTITAK 6.0 MM ABSORBABLE ANCHOR SYSTEM BONUTTI RESEARCH, INC. 510(k) NO: K052799(TRADITIONAL) ATTN: PATRICK BALSMANN PHONE NO : 217-342-3412 P O BOX 1367 SE DECISION MADE: 16-DEC-05 EFFINGHAM, IL 62401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERLING OTW PTA BALLOON DILATATION CATHETER, MODEL H74939032-XX BOSTON SCIENTIFIC CORP. 510(k) NO: K053116(TRADITIONAL) ATTN: MAUREEN MARY MONTBRIAND PHONE NO : 763-494-2903 TWO SCIMED PLACE SE DECISION MADE: 16-DEC-05 MAPLE GROVE, MN 55311-1566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERLING MONORAIL PTA BALLOON DILATATION CATHETER, MODEL H749390 BOSTON SCIENTIFIC CORP. 510(k) NO: K053118(TRADITIONAL) ATTN: MAUREEN MARY MONTBRIAND PHONE NO : 763-494-2903 TWO SCIMED PLACE SE DECISION MADE: 16-DEC-05 MAPLE GROVE, MN 55311-1566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BRECOMP BREDENT-PRODUCTS FOR THE DENTAL TE510(k) NO: K052779(TRADITIONAL) ATTN: MARKUS DENK PHONE NO : 497 462 91300 SCHWARZWALDSTR 11 SE DECISION MADE: 20-DEC-05 TUTTLINGEN, GERMANY 78532 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DENTAPLAST HOT, MODEL 16-XXX BREDENT-PRODUCTS FOR THE DENTAL TE510(k) NO: K052780(TRADITIONAL) ATTN: MARKUS DENK PHONE NO : 497 462 91300 SCHWARZWALDSTR 11 SE DECISION MADE: 21-DEC-05 TUTTLINGEN, GERMANY 78532 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BREFORMANCE BREDENT-PRODUCTS FOR THE DENTAL TE510(k) NO: K052781(TRADITIONAL) ATTN: MARKUS DENK PHONE NO : 497 462 91300 SCHWARZWALDSTR 11 SE DECISION MADE: 09-DEC-05 TUTTLINGEN, GERMANY 78532 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FULL BREATH SLEEP APPLIANCE - AB (ANTERIOR BITE) BRYAN KEROPIAN DDS 510(k) NO: K052862(TRADITIONAL) ATTN: BRYAN KEROPIAN PHONE NO : 818-881-7233 18607 VENTURA BLVD., SUITE 206 SE DECISION MADE: 30-DEC-05 TARZANA, CA 91356 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXTENDSURE HBFASC CONTROL CANTEBURY SCIENTIFIC LTD. 510(k) NO: K053031(TRADITIONAL) ATTN: MAURICE OWEN PHONE NO : 643 343 3345 14 POPE STREET SE DECISION MADE: 07-DEC-05 CHRISTCHURCH, CANTERBURY, NEW ZEAL510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASCENT PIT & FISSURE SEALANT CAO GROUP, INC. 510(k) NO: K053089(TRADITIONAL) ATTN: ROBERT K LARSEN PHONE NO : 801-256-9282 8683 SOUTH 700 WEST SE DECISION MADE: 20-DEC-05 SANDY, UT 84070 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BP PRO BLOOD PRESSURE MONITOR CARD GUARD SCIENTIFIC SURVIVAL, LT510(k) NO: K053395(TRADITIONAL) ATTN: ALEX GONOROVSKY PHONE NO : 972 8 9484019 2 PEKERIS ST. SE DECISION MADE: 23-DEC-05 PO BOX 527 510(k) SUMMARY AVAILABLE FROM FDA REHOVOT, ISRAEL 76100 DEVICE: SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBD CARDINAL HEALTH, ALARIS PRODUCTS 510(k) NO: K052790(TRADITIONAL) ATTN: STACY L LEWIS PHONE NO : 858-458-7830 10221 WATERIDGE CIRCLE SE DECISION MADE: 23-DEC-05 SAN DIEGO, CA 92121-2772 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDIOCOM COMMANDER III CARDIOCOM LLC 510(k) NO: K053303(SPECIAL) ATTN: DANIEL KAMM PHONE NO : 847-374-1727 PO BOX 7007 SE DECISION MADE: 30-DEC-05 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: COMMANDER III NON-INVASIVE BLOOD PRESSURE SYSTEM CARDIOCOM LLC 510(k) NO: K053304(TRADITIONAL) ATTN: DANIEL KAMM PHONE NO : 847-374-1727 PO BOX 7007 SE DECISION MADE: 30-DEC-05 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ADULT CEREBRAL OXIMETER, MODEL 2040 CAS MEDICAL SYSTEMS, INC. 510(k) NO: K051257(TRADITIONAL) ATTN: RON JEFFREY PHONE NO : 203-488-6056 44 EAST INDUSTRIAL RD. SE DECISION MADE: 22-DEC-05 BRANFORD, CT 06405 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODEL 750E SERIES MONITOR CAS MEDICAL SYSTEMS, INC. 510(k) NO: K051896(TRADITIONAL) ATTN: RON JEFFREY PHONE NO : 203-488-6056 44 EAST INDUSTRIAL RD. SE DECISION MADE: 16-DEC-05 BRANFORD, CT 06405 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROTECTOR NEEDLE SHEATH PROP CERTOL INTERNATIONAL, LLC 510(k) NO: K052725(TRADITIONAL) ATTN: LEWIS WARD PHONE NO : 303-530-3279 4655 KIRKWOOD COURT SE DECISION MADE: 28-DEC-05 BOULDER, CO 80301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHEMPAQ XBC ANALYZER CHEMPAQ A/S 510(k) NO: K050758(TRADITIONAL) ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794 555 THIRTEENTH STREET NW SE DECISION MADE: 22-DEC-05 WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDIQ VERSION 1.0 CLARIO MEDICAL IMAGING, INC. 510(k) NO: K052963(TRADITIONAL) ATTN: PATRICIA A MILBANK PHONE NO : 425-894-9733 725 NORTH STATE STREET SE DECISION MADE: 05-DEC-05 BELLINGHAM, WA 98225 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWERNEB COMEDICA , INC. 510(k) NO: K051964(TRADITIONAL) ATTN: KRISTA OAKES PHONE NO : 972-849-5167 2300 MCDERMOTT ROAD SE DECISION MADE: 01-DEC-05 SUITE 200-207 510(k) SUMMARY AVAILABLE FROM FDA PLANO, TX 75025 DEVICE: COOK FORMULA 418 BILIARY STENT SYSTEM COOK, INC. 510(k) NO: K052539(SPECIAL) ATTN: KAREN BRADBURN PHONE NO : 812-339-2235 750 DANIELS WAY PO BX 489 SE DECISION MADE: 09-DEC-05 BLOOMINGTON, IN 47402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MIRA-FLEX 18 MICROCATHETER COOK, INC. 510(k) NO: K052841(SPECIAL) ATTN: THALIA BRINE PHONE NO : 812-339-2235 750 DANIELS WAY PO BX 489 SE DECISION MADE: 08-DEC-05 BLOOMINGTON, IN 47402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOFINITY (COMFILCON A) SOFT CONTACT LENS COOPERVISION, INC. 510(k) NO: K052560(TRADITIONAL) ATTN: JACK P DOUGLAS PHONE NO : 925-251-6666 5870 STONERIDGE DR. SE DECISION MADE: 06-DEC-05 SUITE 1 510(k) SUMMARY AVAILABLE FROM FDA PLEASANTON, CA 94588 DEVICE: TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM LINE EXTENSION CORDIS NEUROVASCULAR, INC. 510(k) NO: K053197(SPECIAL) ATTN: AMARILYS MACHADO PHONE NO : 786-313-6493 14000 N.W. 57TH CT. SE DECISION MADE: 15-DEC-05 MIAMI LAKES, FL 33014 510(k) STATEMENT DEVICE: MULTIPLE (TOOTH DESENSITIZER) COSMEDENT, INC. 510(k) NO: K052263(TRADITIONAL) ATTN: JAMES L SANDRIK PHONE NO : 312-644-9395 401 NORTH MICHIGAN AVE. SE DECISION MADE: 16-DEC-05 SUITE 2500 510(k) SUMMARY AVAILABLE FROM FDA CHICAGO, IL 60611 DEVICE: CURAE'LASE CL1000 IR LASER SYSTEM CURAE'LASE INC. 510(k) NO: K053201(TRADITIONAL) ATTN: M. JOYCE HEINRICH PHONE NO : 713-734-4433 12101 CULLEN BLVD., SUITE A SE DECISION MADE: 09-DEC-05 HOUSTON, TX 77047 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GELITA-SPON CURAMEDICAL, BV 510(k) NO: K051911(TRADITIONAL) ATTN: WILLIAM GREENROSE PHONE NO : 603-369-3550 220 RIVER ROAD SE DECISION MADE: 06-DEC-05 CLAREMONT, NH 03743 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CYBERSONICS CYBERWAND DUAL PROBE LITHOTRIPTER CYBERSONICS, INC. 510(k) NO: K052135(ABBREVIATED) ATTN: WILLIAM A STOLL PHONE NO : 814-899-4220 5368 KUHL RD. SE DECISION MADE: 20-DEC-05 ERIE, PA 16510-4703 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBR DADE BEHRING, INC. 510(k) NO: K053104(TRADITIONAL) ATTN: ANDREA M TASKER PHONE NO : 302-631-9454 GLASGOW BUSINESS COMMUNITY SE DECISION MADE: 23-DEC-05 P.O. BOX 6101 BUILDING 500 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714-6101 DEVICE: DIMENSION CARDIOPHASE HIGH SENSITIVITY CRP FLEX REAGENT CARTRIDG DADE BEHRING, INC. 510(k) NO: K053109(TRADITIONAL) ATTN: ANDREA M TASKER PHONE NO : 302-631-9454 GLASGOW BUSINESS COMMUNITY; SE DECISION MADE: 23-DEC-05 BLDG. 500 P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714-6101 DEVICE: AUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48A DADE BEHRING, INC. 510(k) NO: K053157(SPECIAL) ATTN: VICTOR M CARRIO PHONE NO : 302-631-0376 P.O. BOX 6101 BUILDING 500 SE DECISION MADE: 09-DEC-05 GLASGOW BUSINESS COMMUNITY 510(k) SUMMARY AVAILABLE FROM FDA NEWARK,, DE 19714 DEVICE: READMYHEART, MODEL RMH2.0 DAILYCARE BIOMEDICAL INC 510(k) NO: K052303(TRADITIONAL) ATTN: DANIEL J. H. CHANG PHONE NO : 886 326 21688 8F, 25-3 JI-LIN ROAD SE DECISION MADE: 16-DEC-05 CHUNGLI, CHINA (TAIWAN) 320 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELLIPSE FLEX PPT, MODEL 9ESF7255 DANISH DERMATOLOGIC DEVELOPMENT A/510(k) NO: K052688(ABBREVIATED) ATTN: OLE KOFOD PHONE NO : 454 576 8808 AGERN ALLE 11 SE DECISION MADE: 12-DEC-05 HOERSHOLM, DENMARK DK-2970 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOPURE MTAD ROOT CANAL CLEANSER DENTSPLY INTL., INC. 510(k) NO: K053167(SPECIAL) ATTN: HELEN LEWIS PHONE NO : 717-845-7511 SUSQUEHANNA COMMERCE CENTER SE DECISION MADE: 08-DEC-05 221W PHILADELPHIA ST. SUITE 60 510(k) SUMMARY AVAILABLE FROM FDA YORK, PA 17404 DEVICE: IGI-SYSTEM DENX ADVANCED DENTAL SYSTEMS 510(k) NO: K052840(TRADITIONAL) ATTN: RACHEL WEISSBROD PHONE NO : +97 226 417748 MOSHAV ORA 106 SE DECISION MADE: 16-DEC-05 JERUSALEM, AL, ISRAEL 90880 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: TOTAL BILE ACIDS ASSAY, MODEL DZ042A DIAZYME LABORATORIES 510(k) NO: K051714(TRADITIONAL) ATTN: HUAN TRAN PHONE NO : 858-455-4761 3550 GENERAL ATOMICS CT. SE DECISION MADE: 07-DEC-05 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE DOCTOR'S RESEARCH GROUP, INC. 510(k) NO: K051487(TRADITIONAL) ATTN: MAHMUD AHMED PHONE NO : 860-282-1479 50 ALTAIR AVE. SE DECISION MADE: 22-DEC-05 PLYMOUTH, CT 06782 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL DRG INTL., INC. 510(k) NO: K051733(TRADITIONAL) ATTN: GARY LEHNUS PHONE NO : 570-620-0198 150 CHERRY LANE RD. SE DECISION MADE: 07-DEC-05 EAST STROUDSBURG, PA 18301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DUOPROSS NEEDLE DUOPROSS MEDITECH CORPORATION 510(k) NO: K052445(TRADITIONAL) ATTN: FRANK FERGUSON PHONE NO : 505-332-8445 12200 ACADEMY ROAD NE SE DECISION MADE: 05-DEC-05 # 931 510(k) SUMMARY AVAILABLE FROM FDA ALBUQUERQUE, NM 87111 DEVICE: DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL DYNAREX CORP. 510(k) NO: K052743(TRADITIONAL) ATTN: JAMES HURLMAN PHONE NO : 845-365-8200 10 GLENSHAW ST. SE DECISION MADE: 22-DEC-05 ORANGEBURG, NY 10962 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: E-SAN BLUETOOTH CRADLE E-SAN LIMITED 510(k) NO: K052343(TRADITIONAL) ATTN: KRISTIN M ZIELINSKI PHONE NO : 202-822-1853 2001 PENNSYLVANIA AVE. NW. SE DECISION MADE: 07-DEC-05 STE 575 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20006 DEVICE: E-Z-EM ENDOSCOPIC CO2 REGULATOR E-Z-EM, INC. 510(k) NO: K053008(ABBREVIATED) ATTN: ROBERT WILLIAMS PHONE NO : 516-333-8230 750 SUMMA AVE. SE DECISION MADE: 27-DEC-05 WESTBURY, NY 11590 510(k) STATEMENT DEVICE: EASYSTIM NMS-28 EASYMED INSTRUMENT CO., LTD. 510(k) NO: K050921(ABBREVIATED) ATTN: JEFFERY WU PHONE NO : 86 757 27727282 2/F-3/F, NO.2 BEIHAI DA ROAD SE DECISION MADE: 12-DEC-05 LUNJIAO, SHUNDE 510(k) SUMMARY AVAILABLE FROM FDA GUANGDONG, CHINA 528303 DEVICE: WIRELESS PHYSIOLOGIC MONITORING SYSTEM EDWARDS LIFESCIENCES, LLC. 510(k) NO: K053016(TRADITIONAL) ATTN: DIANE PETERSON PHONE NO : 949-250-2500 ONE EDWARDS WAY SE DECISION MADE: 30-DEC-05 IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIFESTENT FLEXSTART BILIARY STENT SYSTEM EDWARDS LIFESCIENCES, LLC. 510(k) NO: K053404(SPECIAL) ATTN: KEVIN DRISKO PHONE NO : 949-250-2416 ONE EDWARDS WAY SE DECISION MADE: 21-DEC-05 IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EKOS MICRO-INFUSION SYSTEM EKOS CORP. 510(k) NO: K053432(SPECIAL) ATTN: JOCELYN KERSTEN PHONE NO : 425-482-1109 22030 20TH AVENUE S.E. SE DECISION MADE: 30-DEC-05 SUITE 101 510(k) SUMMARY AVAILABLE FROM FDA BOTHELL, WA 98021 DEVICE: SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL ELECTROMED, INC. 510(k) NO: K053248(TRADITIONAL) ATTN: CHET SIEVERT PHONE NO : 651-246-8621 103 EDGECUMBE DRIVE SE DECISION MADE: 01-DEC-05 MAHTOMEDI, MN 55115 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: EVMS (ENTERPRISE VISUAL MEDICAL SYSTEM SOFTWARE) EMAGEON INC. 510(k) NO: K053281(TRADITIONAL) ATTN: INGER L HANSON PHONE NO : 608-256-7775 10 WEST MIFFLIN ST. SE DECISION MADE: 07-DEC-05 SUITE 400 510(k) SUMMARY AVAILABLE FROM FDA MADISON, WI 53704 THIRD PARTY REVIEW DEVICE: ENCORE CLP OFFSET TOTAL HIP SYSTEM ENCORE MEDICAL CORPORATION 510(k) NO: K052320(TRADITIONAL) ATTN: SAM SON PHONE NO : 410-785-0700 11201 PEPPER ROAD SE DECISION MADE: 30-DEC-05 HUNT VALLEY, MD 21031 510(k) STATEMENT DEVICE: ESTECH COBRA BIPOLAR SYSTEM ENDOSCOPIC TECHNOLOGIES, INC. 510(k) NO: K053100(TRADITIONAL) ATTN: CRAIG COOMBS PHONE NO : 510-337-0140 1193 SHERMAN STREET SE DECISION MADE: 19-DEC-05 ALAMEDA, CA 94501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REMOTE ACCESS PERFUSION (RAP) FEMORAL VENOUS CANNULA ESTECH, INC. 510(k) NO: K052081(TRADITIONAL) ATTN: CRAIG COOMBS PHONE NO : 510-337-0140 1193 SHERMAN STREET SE DECISION MADE: 16-DEC-05 ALAMEDA, CA 94501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRACHEOSCOPIC VENTILATION TUBE (TVT) SYSTEM ETVIEW LTD. 510(k) NO: K052233(TRADITIONAL) ATTN: YORAM LEVY PHONE NO : 972 463 88837 31 HAAVODA ST. SE DECISION MADE: 13-DEC-05 BINYAMINA, ISRAEL 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMMUNOSCAN RA ANTI-CCP TEST SYSTEM EURODIAGNOSTICA 510(k) NO: K052133(TRADITIONAL) ATTN: WILLIAM L BOTELER JR. PHONE NO : 301-695-7920 1306 BAILES LANE, SUITE F SE DECISION MADE: 12-DEC-05 FREDERICK, MD 21701 510(k) STATEMENT DEVICE: ACUMATCH M-SERIES LPB 12/14 FEMORAL STEM EXACTECH, INC. 510(k) NO: K051858(SPECIAL) ATTN: LISA SIMPSON PHONE NO : 352-377-1140 2320 N.W. 66TH CT. SE DECISION MADE: 01-DEC-05 GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUMATCH 12/14 C-SERIES CEMENTED FEMORAL STEMS (SIZE 1-6), ACUMA EXACTECH, INC. 510(k) NO: K052787(SPECIAL) ATTN: MARITZA ELIAS PHONE NO : 352-377-1140 2320 N.W. 66TH CT. SE DECISION MADE: 27-DEC-05 GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES EXCELSIOR MEDICAL CORP. 510(k) NO: K053120(SPECIAL) ATTN: RUBEN MARTINEZ PHONE NO : 732-776-7525 1923 HECK AVE. SE DECISION MADE: 09-DEC-05 NEPTUNE, NJ 07753 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1 FEMSPEC L.L.C. 510(k) NO: K051294(TRADITIONAL) ATTN: CARL YOUNGMANN PHONE NO : 360-379-3660 1530 HOLCOMB STREET SE DECISION MADE: 21-DEC-05 PORT TOWNSEND, WA 98368 510(k) STATEMENT DEVICE: FIRST CHECK MULTI DRUG CUP 12 FOR MARIJUANA (THC), COCAINE (COC) FIRST CHECK DIAGNOSTICS LLC 510(k) NO: K052115(TRADITIONAL) ATTN: KEVIN J GADAWSKI PHONE NO : 949-598-8378 13 SPECTRUM POINTE DR. SE DECISION MADE: 29-DEC-05 LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FU HONG INDUSTRIES LIMITED SOOTHER TEETHER FU HONG INDUSTRIES LTD. 510(k) NO: K052531(TRADITIONAL) ATTN: KEVIN WALLS PHONE NO : 720-962-5412 13 RED FOX LANE SE DECISION MADE: 14-DEC-05 LITTLETON, CO 80127 510(k) STATEMENT DEVICE: VITROS CA 19-9 FUJIREBIO DIAGNOSTICS, INC. 510(k) NO: K052889(TRADITIONAL) ATTN: DIANA L WOLANIUK PHONE NO : 610-240-3917 201 GREAT VALLEY PKWY. SE DECISION MADE: 20-DEC-05 MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GAMBRO POLYFLUX HEMODIALYZER, MODEL 6H GAMBRO RENAL PRODUCTS 510(k) NO: K051520(TRADITIONAL) ATTN: THOMAS B DOWELL PHONE NO : 303-231-4094 10810 WEST COLLINS AVE. SE DECISION MADE: 09-DEC-05 LAKEWOOD, CO 80215 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.3 GE HEALTHCARE 510(k) NO: K052972(SPECIAL) ATTN: JOEL KENT PHONE NO : 781-449-8685 86 PILGRIM ROAD SE DECISION MADE: 29-DEC-05 NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE VOLUSON I GENERAL ELECTRIC CO. 510(k) NO: K053435(SPECIAL) ATTN: ALLEN SMITH PHONE NO : 414-647-4385 4855 WEST ELECTRIC AVENUE SE DECISION MADE: 16-DEC-05 PO BOX 414 510(k) SUMMARY AVAILABLE FROM FDA MILWAUKEE, WI 53201 DEVICE: SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH GENZYME CORPORATION 510(k) NO: K053066(TRADITIONAL) ATTN: LISA D CROCKETT PHONE NO : 617-591-5548 55 CAMBRIDGE PARKWAY SE DECISION MADE: 19-DEC-05 CAMBRIDGE, MA 02142 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHODONTIC POLYMER COMPOSITE BRACKET GESTENCO INTERNATIONAL AB 510(k) NO: K053055(TRADITIONAL) ATTN: GORAN STEEN PHONE NO : 463 181 0035 14 FRIDKULLAGATAN SE DECISION MADE: 22-DEC-05 GOTEBORG, SWEDEN SE 400 22 510(k) STATEMENT DEVICE: GIVEN DIAGNOSTIC SYSTEM GIVEN IMAGING LTD. 510(k) NO: K052184(TRADITIONAL) ATTN: SHOSHANA FRIEDMAN PHONE NO : 972 490 97784 SHAAR YOKNEAM (HERMON BUILDING SE DECISION MADE: 01-DEC-05 NEW INDUSTRIAL ZONE, 510(k) SUMMARY AVAILABLE FROM FDA YOKNEAM (P.O.BOX 258), ISRAEL 20692 DEVICE: GREAT GLOVE POWDERED VINYL EXAMINATION GLOVES GREAT GLOVE (CHINA), INC. 510(k) NO: K052922(TRADITIONAL) ATTN: K.M. LEE PHONE NO : +86 512 58422860 3-4 FLOOR, NO.16 HUA CHANG RD. SE DECISION MADE: 20-DEC-05 ZHANGJIAGANG, JIANGSU, CHINA 21560510(k) STATEMENT DEVICE: GREAT GLOVE POWDER FREE VINYL EXAMINATION GLOVES GREAT GLOVE (CHINA), INC. 510(k) NO: K052923(TRADITIONAL) ATTN: K.M. LEE PHONE NO : +86 512 5842260 3-4 FLOOR, NO.16 HUA CHANG RD. SE DECISION MADE: 21-DEC-05 ZHANGJIAGANG, JIANGSU, CHINA 21560510(k) STATEMENT DEVICE: NITRILE BLUE POWDER FREE EXAMINATION GLOVE GREAT GLOVE SDN BHD 510(k) NO: K052956(TRADITIONAL) ATTN: LIM WEE-CHAI PHONE NO : 603 339 27880 LOT 5091, SALAN TERATAI, BATU SE DECISION MADE: 21-DEC-05 5, OFF; JALAN MERU 510(k) STATEMENT KLANG, SELANGOR, MALAYSIA 41050 DEVICE: POWDER FREE STERILE LATEX SURGICAL GLOVES HARTALEGA SDN BHD 510(k) NO: K052177(TRADITIONAL) ATTN: NURUL AISYAH KONG PHONE NO : 603 627 42177 9 JALAN KUANG BULAN TAMAN SE DECISION MADE: 09-DEC-05 KEPONG INDUSTRIAL ESTATE 510(k) STATEMENT KUALA LUMPUR, MALAYSIA 52100 DEVICE: HDC SPIDER SCREW HDC S.R.L. 510(k) NO: K052471(TRADITIONAL) ATTN: MILLIE LYNN BENTLEY PHONE NO : 301-263-0544 6512 BANNOCKBURN DRIVE SE DECISION MADE: 23-DEC-05 BETHESDA, MD 20817 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LUMIMED MONOCHROME LCD MONITOR, MODELS MM 20, MM 30 AND MM50 HEEYOUNG CO., LTD. 510(k) NO: K052120(TRADITIONAL) ATTN: DANIEL KAMM PHONE NO : 847-374-1727 P.O. BOX 7007 SE DECISION MADE: 16-DEC-05 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER HITACHI MEDICAL CORP. 510(k) NO: K053258(SPECIAL) ATTN: DOUG THISTLETHWAITE PHONE NO : 330-425-1313 1959 SUMMIT COMMERCE PARK SE DECISION MADE: 09-DEC-05 TWINSBURG, OH 44087 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BREATHEX OMEGA CPAP DEVICE, MODEL 322 HOFFMAN LABORATORIES, LLC 510(k) NO: K052597(TRADITIONAL) ATTN: KEITH BOSECKER PHONE NO : 818-341-4131 9305 ETON AVENUE SE DECISION MADE: 16-DEC-05 CHATSWORTH, CA 91311 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODUL HORIBA ABX 510(k) NO: K052007(TRADITIONAL) ATTN: TIM LAWTON PHONE NO : 33 467 147320 PARC EUROMEDECINE SE DECISION MADE: 16-DEC-05 RUE DU CADUCEE 510(k) SUMMARY AVAILABLE FROM FDA MONTPELLIER, HERAULT, FRANCE 34184 DEVICE: ABX MICROS CRP 200, OPTION IM HORIBA ABX 510(k) NO: K053308(SPECIAL) ATTN: TIM LAWTON PHONE NO : 33 467 147320 PARC EUROMEDECINE SE DECISION MADE: 29-DEC-05 RUE DU CADUCEE 510(k) SUMMARY AVAILABLE FROM FDA MONTPELLIER, HERAULT, FRANCE 34184 DEVICE: SYSTEM 12 X3 ACETABULAR INSERTS; SERIES II X3 ACETABULAR INSERTS HOWMEDICA OSTEONICS CORP 510(k) NO: K052748(TRADITIONAL) ATTN: KAREN ARIEMMA PHONE NO : 201-831-5718 325 CORPORATE DR. SE DECISION MADE: 02-DEC-05 MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRYKER COMPARTMENTAL KNEE SYSTEM HOWMEDICA OSTEONICS CORP 510(k) NO: K052917(TRADITIONAL) ATTN: VIVIAN KELLY PHONE NO : 201-831-5581 325 CORPORATE DR. SE DECISION MADE: 27-DEC-05 MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HOFFMANN II ROD TO WIRE COUPLING HOWMEDICA OSTEONICS CORP 510(k) NO: K053349(SPECIAL) ATTN: FRANCISCO HARO PHONE NO : 201-831-5493 325 CORPORATE DR. SE DECISION MADE: 09-DEC-05 MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HSINER JET NEBULIZER, MODEL HS-31100 HSINER CO., LTD. 510(k) NO: K052811(TRADITIONAL) ATTN: TOM SHANKS PHONE NO : 951-506-2674 29201 VIA NORTE SE DECISION MADE: 21-DEC-05 TEMECULA, CA 92591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDILOG DARWIN HOLTER ANALYSIS HUNTLEIGH HEALTHCARE 510(k) NO: K053369(TRADITIONAL) ATTN: JAMES PARDEY PHONE NO : 441 483 746421 LION HOUSE; ORIENTAL ROAD SE DECISION MADE: 22-DEC-05 WORKING 510(k) SUMMARY AVAILABLE FROM FDA SURREY, UNITED KINGDOM GU22 8 AP THIRD PARTY REVIEW DEVICE: BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202 HYPHEN BIOMED 510(k) NO: K050365(TRADITIONAL) ATTN: OLA ANDERSON PHONE NO : 513-770-1993 6560 GOVE CT. SE DECISION MADE: 27-DEC-05 MASON, OH 45040 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CAL HYPHEN BIOMED 510(k) NO: K051472(TRADITIONAL) ATTN: OLA ANDERSON PHONE NO : 513-770-1993 6560 GOVE CT. SE DECISION MADE: 23-DEC-05 MASON, OH 45040 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: I-STAT CREATINE KINASE MB (CK-MB) I-STAT CORPORATION 510(k) NO: K051433(TRADITIONAL) ATTN: SUE KENT PHONE NO : 609-443-9300 104 WINDSOR CENTER DRIVE SE DECISION MADE: 15-DEC-05 EAST WINDSOR, NJ 08520 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HOSPIRA CATH LAB CONVENIENCE KITS ICU MEDICAL, INC. 510(k) NO: K052865(SPECIAL) ATTN: TOM KOZMA PHONE NO : 224-212-4803 275 NORTH FIELD DRIVE SE DECISION MADE: 22-DEC-05 LAKE FOREST, IL 60045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES. IND DIAGNOSTIC INC. 510(k) NO: K052694(TRADITIONAL) ATTN: JASON PENG PHONE NO : 604 522 1619 1629 FOSTERS WAY SE DECISION MADE: 16-DEC-05 DELTA, BC, CANADA V3M 6S7 510(k) STATEMENT DEVICE: IST PEDICLE SCREW SYSTEM INNOVATIVE SPINAL TECHNOLOGIES INC510(k) NO: K053276(TRADITIONAL) ATTN: STEPHEN PALUMBO PHONE NO : 508-618-1295 PO BOX 110 SE DECISION MADE: 27-DEC-05 MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECLIPSE (CABINET NAME), TEOAE25, EP15, OR THE COMBINATION OF SYS INTERACOUSTICS AS 510(k) NO: K052562(TRADITIONAL) ATTN: DANIEL EGGAN PHONE NO : 952-903-4157 7625 GOLDEN TRIANGLE DRIVE SE DECISION MADE: 23-DEC-05 EDEN PRAIRIE, MN 55344 510(k) STATEMENT DEVICE: INTERBODY INNOVATIONS CEMENT RESTRICTOR INTERBODY INNOVATIONS LLP 510(k) NO: K051371(TRADITIONAL) ATTN: IAN GORDON PHONE NO : 727-797-4727 2454 MCMULLEN BOOTH RD. SE DECISION MADE: 06-DEC-05 SUITE 427 510(k) SUMMARY AVAILABLE FROM FDA CLEARWATER, FL 33759 DEVICE: ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) INVERNESS MEDICAL INNOVATIONS, INC510(k) NO: K053196(SPECIAL) ATTN: JAMES M DELANEY PHONE NO : 978-475-5692 51 SAWYER RD., SUITE 200 SE DECISION MADE: 16-DEC-05 WALTHAM, MA 02453-3448 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHOBLAST II PUTTY AND PASTE ISOTIS ORTHOBIOLOGICS, INC 510(k) NO: K050642(TRADITIONAL) ATTN: PAUL DONER PHONE NO : 949-595-8710 2 GOODYEAR, SUITE B SE DECISION MADE: 05-DEC-05 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1 EXF J. MORITA USA, INC. 510(k) NO: K052587(TRADITIONAL) ATTN: KEITH A BARRITT PHONE NO : 202-783-5070 1425 K STREET NW SE DECISION MADE: 27-DEC-05 SUITE 1100 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20005 DEVICE: MESA SPINAL SYSTEM K2M, LLC 510(k) NO: K052398(TRADITIONAL) ATTN: RICHARD W WOODS PHONE NO : 703-777-3155 751 MILLER DR.,S.E., SUITE F1 SE DECISION MADE: 07-DEC-05 LEESBURG, VA 20175 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROBIN HOOD VEST KAMBER CORPORATION 510(k) NO: K051300(TRADITIONAL) ATTN: DAVID J BLOCH PHONE NO : 202-414-9200 1301 K STREET, N.W. SE DECISION MADE: 08-DEC-05 SUITE 1100 - EAST TOWER 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20005-3373 DEVICE: K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET KAMIYA BIOMEDICAL CO. 510(k) NO: K050944(TRADITIONAL) ATTN: BRIAN SCHLIESMAN PHONE NO : 206-575-8068 12779 GATEWAY DR. SE DECISION MADE: 23-DEC-05 SEATTLE, WA 98168 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K053262(TRADITIONAL) ATTN: YVONNE FERNANDEZ PHONE NO : 310-348-4226 600 CORPORATE POINTE SE DECISION MADE: 19-DEC-05 CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DS CASSETTE KONICA MINOLTA MEDICAL & GRAPHIC, 510(k) NO: K053173(TRADITIONAL) ATTN: SHINICHI YAMANAKA PHONE NO : +81 596 370190 319 AKENO, OBATA-CHO SE DECISION MADE: 15-DEC-05 WATARAI-GUN 510(k) SUMMARY AVAILABLE FROM FDA MIE-KEN, JAPAN 519-05 DEVICE: BRAIN VIEWRX VIEWER, VERSION 1.0 KYRON CLINICAL IMAGING, INC. 510(k) NO: K052467(TRADITIONAL) ATTN: JAMES L REUSS PHONE NO : 414-745-3042 W290 S2837 CARMARTHEN DR. SE DECISION MADE: 20-DEC-05 WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STARLITE 2006 LASER DENTAL INNOVATIONS 510(k) NO: K052604(TRADITIONAL) ATTN: HOWARD FEINBERG PHONE NO : 877-753-5054 745 DUBANSKI DR. SE DECISION MADE: 16-DEC-05 SAN JOSE, CA 95123 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPIRO-BALL LEVENTON, S.A. 510(k) NO: K053149(TRADITIONAL) ATTN: ORIOL VERNIS PHONE NO : 349 381 76300 C/NEWTON 18-24, POLIGONO SE DECISION MADE: 13-DEC-05 INDUSTRIAL SESROVIRES, SANT 510(k) SUMMARY AVAILABLE FROM FDA ESTEVE SESROVIRES, BARCELONA, SPAITHIRD PARTY REVIEW DEVICE: CAREO SAFETY SYRINGE (3CC/ML, 5CC/ML, 10CC/ML) LIFE-SHIELD PRODUCTS, INC 510(k) NO: K052397(TRADITIONAL) ATTN: KE-MIN JEN PHONE NO : 886 3 5208829 3F, NO 10, WUCHIUAN 7TH RD SE DECISION MADE: 22-DEC-05 WUGU INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA TAIPEI, CHINA (TAIWAN) 248 DEVICE: ALLOCRAFT DBM LIFECELL CORP. 510(k) NO: K052735(TRADITIONAL) ATTN: HOWARD M HOLSTEIN PHONE NO : 202-637-5813 555 13TH STREET, NW SE DECISION MADE: 28-DEC-05 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AQ-830 SLIM BODY, BODY FAT MONITOR LIMAX ELECTRONICS CO., LTD. 510(k) NO: K052678(TRADITIONAL) ATTN: JENNIFER REICH PHONE NO : 928-773-9488 2904 N. BOLDT DRIVE SE DECISION MADE: 27-DEC-05 FLAGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIMERICK PJ'S COMFORT JR PORTABLE ELECTRIC BREAST PUMP LIMERICK, INC. 510(k) NO: K051926(TRADITIONAL) ATTN: PAUL KRUMM PHONE NO : 785-472-3712 1313-23RD ROAD SE DECISION MADE: 12-DEC-05 KANOPOLIS, KS 67454 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CALM CURVE, VERSION 01.00 LMS MEDICAL SYSTEMS (CANADA), LTD.510(k) NO: K052715(SPECIAL) ATTN: PAMELA HASWELL PHONE NO : 514 488 3461X246 5252 DE MAISONNEUVE WEST, #314 SE DECISION MADE: 22-DEC-05 MONTREAL, QC, CANADA H4A 3S5 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE LATEX STERILE PATIENT EXAMINATION GLOVES M/S. KANAM LATEX INDUSTRIES PVT. L510(k) NO: K052728(TRADITIONAL) ATTN: RAVI ABRAHAM PHONE NO : 914 812 300343 OOPPOOTTIL BUILDINGS, K.K.ROAD SE DECISION MADE: 05-DEC-05 KOTTAYAM, KERALA, INDIA 686001 510(k) STATEMENT DEVICE: TEWA CJ-TYPE, PJ-TYPE, CB-TYPE AND PB-TYPE ACUPUNCTURE NEEDLES F MAANSHAN MEDICAL INSTRUMENTS CO., 510(k) NO: K052846(TRADITIONAL) ATTN: KEVIN WALLS PHONE NO : 720-962-5412 13 RED FOX LANE SE DECISION MADE: 22-DEC-05 LITTLETON, CO 80127 510(k) STATEMENT DEVICE: MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT MACAN ENGINEERING CO. 510(k) NO: K052622(TRADITIONAL) ATTN: MICKEY ALBERGO PHONE NO : 773-772-2000 1564 NORTH DAMEN AVE. SE DECISION MADE: 09-DEC-05 CHICAGO, IL 60622 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MANI NEEDLE & SUTURE PACK MANI, INC. 510(k) NO: K050150(TRADITIONAL) ATTN: DAVID J BLOCH PHONE NO : 202-414-9202 1301 K STREET, N.W. SE DECISION MADE: 05-DEC-05 SUITE 1100 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20005 DEVICE: MARIETTA CONTACT LENS (POLYMACON), TINTED DAILY WEAR CONTACT LEN MARIETTA VISION 510(k) NO: K052606(SPECIAL) ATTN: MARTIN DALSING PHONE NO : 970-243-5490 2214 SANFORD DR. SUITE #B7 SE DECISION MADE: 15-DEC-05 GRAND JUNCTION, CO 81505 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MASIMO SET RAD-8 PULSE OXIMETER MASIMO CORPORATION 510(k) NO: K053269(SPECIAL) ATTN: JIM CRONIN PHONE NO : 949-297-7218 40 PARKER SE DECISION MADE: 21-DEC-05 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDI BAYREUTH MEDI USA, LP 510(k) NO: K051324(TRADITIONAL) ATTN: GARY L YINGLING PHONE NO : 202-778-9124 1800 MASSACHUSETTS AVE., N.W. SE DECISION MADE: 05-DEC-05 WASHINGTON, DC 20036-1221 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLICKZIP NEEDLE RETRACTABLE SAFETY SYRINGE MEDICAL DEVICE MANUFACTURER (THAIL510(k) NO: K051694(ABBREVIATED) ATTN: OYTIP KUNWUNLOP PHONE NO : 66 1 8447959 7/145 MOO 4 SE DECISION MADE: 21-DEC-05 AMATA CITY INDUSTRIAL ESTATE 510(k) SUMMARY AVAILABLE FROM FDA RAYONG, THAILAND 21140 DEVICE: SOLAR GI MEDICAL MEASUREMENT SYSTEMS,B.V. 510(k) NO: K052338(SPECIAL) ATTN: KARIN OGINK-SOMHORST PHONE NO : 315 348 03739 COLOSSEUM 25 SE DECISION MADE: 15-DEC-05 ENSCHEDE, NETHERLANDS 7521 PV 510(k) STATEMENT DEVICE: VENTLINK SYSTEM MEDISERVE INFORMATION SYSTEMS, INC510(k) NO: K052751(TRADITIONAL) ATTN: MARK OFORI-KYEI PHONE NO : 480-831-7100 3225 S. HARDY DR., SUITE 101 SE DECISION MADE: 23-DEC-05 TEMPE, AZ 85282 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDISIZE GOLD MEDISIZE BV 510(k) NO: K052615(TRADITIONAL) ATTN: SOPIHA LAM PHONE NO : +31 252 576888 EDISONSTRAAT 1 SE DECISION MADE: 09-DEC-05 HILLEGOM, NETHERLANDS 2180 AB 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: FUGO BLADE FOR PERIPHERAL IRIDOTOMY, MODEL M300 MEDISURG LTD. 510(k) NO: K050933(TRADITIONAL) ATTN: RICHARD J FUGO PHONE NO : 610-277-3937 100 WEST FORNANCE ST. SE DECISION MADE: 09-DEC-05 THE FUGO BUILDING 510(k) SUMMARY AVAILABLE FROM FDA NORRISTOWN, PA 19401 DEVICE: MEDIWATCH MULTISCAN ULTRASOUND SYSTEM/SCANNER, MODEL M0002 (SCAN MEDIWATCH LTD 510(k) NO: K053325(ABBREVIATED) ATTN: ANDREW HOPKINS PHONE NO : 004 417 88547888 SWIFT HOUSE, SWIFT VALLEY SE DECISION MADE: 07-DEC-05 INDUSTRIAL ESATE, RUGBY 510(k) STATEMENT WARWICKSHIRE, UNITED KINGDOM CV 21THIRD PARTY REVIEW DEVICE: LIFEPAK, MODEL 1000 MEDTRONIC EMERGENCY RESPONSE SYSTE510(k) NO: K042404(TRADITIONAL) ATTN: SHERRI POCOCK PHONE NO : 425-867-4332 11811 WILLOWS RD., N.E. SE DECISION MADE: 22-DEC-05 PO BOX 97006 510(k) SUMMARY AVAILABLE FROM FDA REDMOND, WA 98073 DEVICE: MEDTRONIC M2 MAGNET ADJUSTMENT TOOL MEDTRONIC NEUROSURGERY 510(k) NO: K052386(TRADITIONAL) ATTN: JEFFREY HENDERSON PHONE NO : 805-968-1546 125 CREMONA DR. SE DECISION MADE: 16-DEC-05 GOLETA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MASTERGRAFT PUTTY BONE VOID FILLER MEDTRONIC, INC. 510(k) NO: K051386(TRADITIONAL) ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 16-DEC-05 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: U-CLIP DEVICE, MODELS B140, B160 AND B180 MEDTRONIC, INC. 510(k) NO: K053252(SPECIAL) ATTN: DAVID D COX PHONE NO : 763-391-9251 7601 NORTHLAND DR. SE DECISION MADE: 16-DEC-05 MINNEAPOLIS, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITALOGIK MENNEN MEDICAL LTD. 510(k) NO: K052288(SPECIAL) ATTN: MICHA OESTEREICH PHONE NO : 972 893 23333 4 HAYARDEN ST. SE DECISION MADE: 20-DEC-05 YAVNE, ISRAEL 81228 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MENTOR NOVASILK MESH MENTOR CORP. 510(k) NO: K053414(TRADITIONAL) ATTN: DONNA A CRAWFORD PHONE NO : 805-879-6304 201 MENTOR DRIVE SE DECISION MADE: 27-DEC-05 SANTA BARBARA, CA 93111 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MENTOR ARIS SUPRAPUBIC SURGICAL KIT MENTOR CORPORATION 510(k) NO: K053296(TRADITIONAL) ATTN: DONNA A CRAWFORD PHONE NO : 805-879-6304 201 MENTOR DRIVE SE DECISION MADE: 15-DEC-05 SANTA BARBARA, CA 93111 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICRUS MODIFIED MICROCOIL 18-SYSTEM, "CERECYTE", MODEL CSP & CHE MICRUS ENDOVASCULAR CORPORATION 510(k) NO: K053160(SPECIAL) ATTN: MARGARET WEBBER PHONE NO : 408-830-5800 610 PALOMAR AVENUE SE DECISION MADE: 07-DEC-05 SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MPS ACACIA MEDFLO ELASTOMERIC PUMP MPS ACACIA 510(k) NO: K052451(TRADITIONAL) ATTN: FERGIE FERGUSON PHONE NO : 714-257-0470 785 CHALLENGER ST. SE DECISION MADE: 08-DEC-05 BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MPS ACACIA NERVE BLOCK NEEDLE MPS ACACIA 510(k) NO: K052946(TRADITIONAL) ATTN: FERGIE F FERGUSON PHONE NO : 714-257-0470 785 CHALLENGER ST. SE DECISION MADE: 08-DEC-05 BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 21.3INCH MONOCHROME LCD MONITOR NEC-MITSUBISHI ELECTRIC VISUAL SYS510(k) NO: K052942(TRADITIONAL) ATTN: SHUICHI KINO PHONE NO : +81 465 852376 4-13-23 SHIBAURA SE DECISION MADE: 27-DEC-05 MINATO-KU, TOKYO, JAPAN 108-0023 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: THERAKNIT GARMENT ELECTRODE NEUROTRON MEDICAL 510(k) NO: K053214(TRADITIONAL) ATTN: JACK GULDALIAN PHONE NO : 609-896-3444 800 SILVIA ST. SE DECISION MADE: 20-DEC-05 EWING, NJ 08628 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: KALIX II IMPLANT, MODEL 141 0XX WITH XX NEWDEAL S.A. 510(k) NO: K053093(SPECIAL) ATTN: JUDITH E O'GRADY PHONE NO : 609-936-2311 311 ENTERPRISE DRIVE SE DECISION MADE: 07-DEC-05 PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEXA BONE SCREW SYSTEM NEXA ORTHOPEDICS, INC. 510(k) NO: K053394(TRADITIONAL) ATTN: LOUISE M FOCHT PHONE NO : 858-866-0660 10675 SORRENTO VALLEY ROAD SE DECISION MADE: 14-DEC-05 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA SAN DIEGO, CA 92121 DEVICE: NEXA BONE PLATE AND SCREW SYSTEM NEXA ORTHOPEDICS, INC. 510(k) NO: K053408(TRADITIONAL) ATTN: LOUISE M FOCHT PHONE NO : 858-866-0660 10675 SORRENTO VALLEY ROAD SE DECISION MADE: 22-DEC-05 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA SAN DIEGO, CA 92121 DEVICE: NEXUSTKO NEEDLELESS ACCESS DEVICE, MODEL NIS-5 NEXUS MEDICAL, LLC 510(k) NO: K053129(SPECIAL) ATTN: AL BOEDEKER PHONE NO : 913-451-2234 11315 STRANG LINE ROAD SE DECISION MADE: 08-DEC-05 LENEXA, KS 66215 510(k) STATEMENT DEVICE: NIPRO SUREFUSER AMBULATORY INFUSION PUMP NIPRO MEDICAL CORPORATION 510(k) NO: K051828(TRADITIONAL) ATTN: KAELYN HADLEY PHONE NO : 859-224-8256 1384 COPPERFIELD COURT SE DECISION MADE: 15-DEC-05 LEXINGTON, KY 40514 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZYGOMA 17 ABUTMENT MULTI-UNIT RP 2MM, MODEL 29314; ZYGOMA 17 ABU NOBEL BIOCARE USA LLC 510(k) NO: K052885(TRADITIONAL) ATTN: HERBERT CRANE PHONE NO : 714-282-5074 22715 SAVI RANCH PARKWAY SE DECISION MADE: 23-DEC-05 YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SILVERSEAL SILVERAID WITH X-STATIC NOBLE FIBER TECHNOLOGIES, INC. 510(k) NO: K050726(TRADITIONAL) ATTN: PATRICIA DAVIDSON PHONE NO : 877-978-2842 421 SOUTH STATE ST. SE DECISION MADE: 05-DEC-05 CLARKS SUMMIT, PA 18411 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODEL 4000, 4100 NONIN MEDICAL, INC. 510(k) NO: K052669(TRADITIONAL) ATTN: LORI M ROTH PHONE NO : 763-577-3093 13700 1ST AVE. NORTH SE DECISION MADE: 23-DEC-05 PLYMOUTH, MN 55441-5443 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOSSEOUS DENTAL IMPLANT SYSTEM NORTHERN IMPLANTS, LLC 510(k) NO: K052490(TRADITIONAL) ATTN: GRETA M HOLS PHONE NO : 703-278-3953 10355 B DEMOCRACY LANE SE DECISION MADE: 08-DEC-05 FAIRFAX, VA 22030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOVOFINE 32G TIP NOVO NORDISK INC. 510(k) NO: K053470(SPECIAL) ATTN: JOHN SIGNORIN PHONE NO : 609-987-5800 SE DECISION MADE: 21-DEC-05 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PANA-SPRAY NSK AMERICA CORP. 510(k) NO: K052700(TRADITIONAL) ATTN: HIROHIKO MURASE PHONE NO : 847-843-7664 700-B COOPER CT. SE DECISION MADE: 20-DEC-05 SCHAUMBURG, IL 60173 510(k) STATEMENT DEVICE: NUVASIVE COROENT EXTENSURE SYSTEM NUVASIVE, INC. 510(k) NO: K052210(SPECIAL) ATTN: LAETITIA COUSIN PHONE NO : 858-909-1868 4545 TOWNE CENTRE CT. SE DECISION MADE: 12-DEC-05 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION NXSTAGE MEDICAL, INC. 510(k) NO: K053286(SPECIAL) ATTN: NORMA LEMAY PHONE NO : 978-687-4700 439 SOUTH UNION ST., 5TH FLOOR SE DECISION MADE: 22-DEC-05 LAWRENCE, MA 01843 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BREATHKEY MODEL G10/BREATHKEY MODEL G30X OMEGAPOINT SYSTEMS, LLC 510(k) NO: K052804(TRADITIONAL) ATTN: BARBARA S FANT PHONE NO : 513-961-8200 310 TERRACE AVENUE, SUITE 201 SE DECISION MADE: 09-DEC-05 CINCINNATI, OH 45220 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: RESOLUTION ENDOVASCULAR SYSTEM OMNISONICS MEDICAL TECHNOLOGIES 510(k) NO: K052428(TRADITIONAL) ATTN: ANNE M KULIS PHONE NO : 978-657-9980 66 CONCORD STREET, SUITE A SE DECISION MADE: 08-DEC-05 WILMINGTON, MA 01887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITRO ORTHO-CLINICAL DIAGNOSTICS 510(k) NO: K052645(TRADITIONAL) ATTN: MICHAEL M BYRNE PHONE NO : 585-453-3143 100 INDIGO CREEK DR. SE DECISION MADE: 14-DEC-05 ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K052819(TRADITIONAL) ATTN: DARLENE J PHILLIPS PHONE NO : 585-453-4253 100 INDIGO CREEK DR. SE DECISION MADE: 23-DEC-05 ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITROS CHEMISTRY PRODUCTS DTIBC REAGENT ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K052867(TRADITIONAL) ATTN: DARLENE J PHILLIPS PHONE NO : 585-453-4253 100 INDIGO CREEK DR. SE DECISION MADE: 23-DEC-05 ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHOFIX TITANIUM NAILING SYSTEMS ORTHOFIX SRL 510(k) NO: K053261(TRADITIONAL) ATTN: CANDACE F CEDERMAN PHONE NO : 910-509-0403 632 DUNDEE DRIVE SE DECISION MADE: 12-DEC-05 WILMINGTON, NC 28405 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIAGRAF DBM PASTE OSTEOTECH, INC. 510(k) NO: K043209(TRADITIONAL) ATTN: CHRISTOPHER TALBOT PHONE NO : 732-542-2800 51 JAMES WAY SE DECISION MADE: 05-DEC-05 EATONTOWN, NJ 07724 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GRAFTON DBM OSTEOTECH, INC. 510(k) NO: K051195(TRADITIONAL) ATTN: CHRISTOPHER W TALBOT PHONE NO : 732-542-2800 51 JAMES WAY SE DECISION MADE: 16-DEC-05 EATONTOWN, NJ 07724 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GRAFTCAGE TLX OSTEOTECH, INC. 510(k) NO: K051781(TRADITIONAL) ATTN: CHRISTOPHER TALBOT PHONE NO : 732-542-2800 51 JAMES WAY SE DECISION MADE: 16-DEC-05 EATONTOWN, NJ 07724 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GRAFTCAGE ACX OSTEOTECH, INC. 510(k) NO: K053080(TRADITIONAL) ATTN: CHRISTOPHER TALBOT PHONE NO : 732-542-2800 51 JAMES WAY SE DECISION MADE: 01-DEC-05 EATONTOWN, NJ 07724 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: A-200 POWERED WHEELCHAIR OTTO BOCK HEALTHCARE, LP 510(k) NO: K052706(TRADITIONAL) ATTN: BOB CLARKE PHONE NO : 763-489-5105 2 CARLSON PKWY., SUITE 100 SE DECISION MADE: 27-DEC-05 MINNEAPOLIS, MN 55447-4467 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OXYHEAL 1000 MONOPLACE HYPERBARIC CHAMBER OXYHEAL HEALTH GROUP 510(k) NO: K052866(ABBREVIATED) ATTN: DAVE HEANY PHONE NO : 619-336-2022 3224 HOOVER AVE. SE DECISION MADE: 13-DEC-05 NATIONAL CITY, CA 91950 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OXYSURE PORTABLE OXYGEN GENERATOR, MODEL 615 OXYSURE SYSTEMS, INC. 510(k) NO: K052396(TRADITIONAL) ATTN: JULIAN T ROSS PHONE NO : 214-618-7918 2611 INTERNET BLVD., SUITE 109 SE DECISION MADE: 09-DEC-05 FRISCO, TX 75034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADAPTABLE MONOPOLAR ELECTRODES WITH CERAMIC TIP PAJUNK GMBH 510(k) NO: K053282(SPECIAL) ATTN: CHRISTIAN QUASS PHONE NO : 049 770 49291533 KARL-HALL-STRASSE 1 SE DECISION MADE: 13-DEC-05 GEISINGEN, GERMANY D-78187 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UROVANTAGE PCK ELECTRONIC INDUSTRY & TRADE CO510(k) NO: K053279(SPECIAL) ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794 555 THIRTEENTH STREET, NW SE DECISION MADE: 22-DEC-05 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COROLENE PETERS SURGICAL 510(k) NO: K052701(TRADITIONAL) ATTN: ANNIE LASSERRE PHONE NO : 003 314 8106259 42 RUE BENOIT FRANCHON SE DECISION MADE: 13-DEC-05 BOBIGNY, FRANCE 93013 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WARMING LIQUID PERSONAL LUBRICANT PHARMAPAC LLC 510(k) NO: K052974(TRADITIONAL) ATTN: TOM OTTO PHONE NO : 601-743-9771 110 INDUSTRIAL PARK ROAD SE DECISION MADE: 16-DEC-05 DEKALB, MS 39329 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PHILIPS AVALON FETAL MONITOR, MODELS FM20 AND FM30 PHILIPS MEDIZINSYSTEME BOEBLINGEN 510(k) NO: K052795(SPECIAL) ATTN: MARKUS STACHA PHONE NO : 49 703 14632840 HEWLETT-PACKARD STR.2 SE DECISION MADE: 30-DEC-05 BOEBLINGEN, GERMANY D 71034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MYLAB15/20 3D/4D ULTRASOUND IMAGING SYSTEM PIE MEDICAL 510(k) NO: K053154(TRADITIONAL) ATTN: CARRI GRAHAM PHONE NO : 317-849-1916 7992 CASTLEWAY DRIVE SE DECISION MADE: 16-DEC-05 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAAS PIE MEDICAL IMAGING B.V. 510(k) NO: K052988(TRADITIONAL) ATTN: CARLA DE VRIES PHONE NO : 31 43 3281322 BECANUSSTRAAT 13 D SE DECISION MADE: 30-DEC-05 MAASTRICHT, NETHERLANDS 6216 BX 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MINIMATE COMPRESSOR PRECISION MEDICAL, INC. 510(k) NO: K051691(TRADITIONAL) ATTN: JAMES PARKER PHONE NO : 610-262-6090 300 HELD DR. SE DECISION MADE: 09-DEC-05 NORTHAMPTON, PA 18067 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRO-FLOW MULTIPURPOSE CANNULA PRO-TECH SERVICES, INC. 510(k) NO: K053063(TRADITIONAL) ATTN: NEIL SHELLER PHONE NO : 425-322-0304 4338 HARBOUR POINTE BLVD. S.W. SE DECISION MADE: 13-DEC-05 MUKILTEO, WA 98275 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, ULTRA ABSORBENCY (UNSCE PROCTER & GAMBLE CO. 510(k) NO: K051290(TRADITIONAL) ATTN: MARK M ANDERSON PHONE NO : 513-634-5196 6110 CENTER HILL AVE. SE DECISION MADE: 27-DEC-05 CINCINNATI, OH 45224 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: I-NEB INSIGHT AAD SYSTEM PROFILE THERAPEUTICS PLC 510(k) NO: K052941(SPECIAL) ATTN: BARBARA CAMPBELL PHONE NO : 724-387-4557 CORPORATE SERVICES SE DECISION MADE: 09-DEC-05 1010 MURRY RIDGE LANE 510(k) SUMMARY AVAILABLE FROM FDA MURRYSVILLE, PA 15668-8525 DEVICE: QUICKVUE INFLUEZA A + B TEST QUIDEL CORP. 510(k) NO: K053146(TRADITIONAL) ATTN: EDWARD M BASILE PHONE NO : 202-626-2645 1730 PENNSYLVANIA AVE., N.W. SE DECISION MADE: 14-DEC-05 WASHINGTON, DC 20006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: T-TEK R2 DIAGNOSTICS, INC. 510(k) NO: K050817(TRADITIONAL) ATTN: PEGGY S CARTER PHONE NO : 574-288-4377 412 SOUTH LAFAYETTE BLVD. SE DECISION MADE: 12-DEC-05 SOUTH BEND, IN 46601 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UTOPIA RESPCARE INC. 510(k) NO: K052249(TRADITIONAL) ATTN: FRANK PELC PHONE NO : 561-208-3778 6601 LYONS ROAD, SUITES B1-B4 SE DECISION MADE: 07-DEC-05 COCONUT CREEK, FL 33073 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MYNEB NEBULIZER, MODEL RDD100 RESPIRONICS NEW JERSEY, INC. 510(k) NO: K053203(TRADITIONAL) ATTN: LAUREN ZIEGLER PHONE NO : 973-571-2608 41 CANFIELD RD. SE DECISION MADE: 20-DEC-05 CEDAR GROVE, NJ 07009 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: STARDUST II RESPIRONICS, INC. 510(k) NO: K052573(TRADITIONAL) ATTN: ZITA A YURKO PHONE NO : 724-387-4120 1001 MURRY RIDGE LN. SE DECISION MADE: 13-DEC-05 MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECSYS PROBNP IMMUNOASSAY ROCHE DIAGNOSTICS CORP. 510(k) NO: K051382(TRADITIONAL) ATTN: THERESA M AMBROSE PHONE NO : 317-521-3723 9115 HAGUE RD. SE DECISION MADE: 05-DEC-05 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ISE INDIRECT NA, K, CL FOR GEN.2 ROCHE DIAGNOSTICS CORP. 510(k) NO: K053165(SPECIAL) ATTN: K AUFMAN PHONE NO : 317-521-7637 9115 HAGUE RD. SE DECISION MADE: 14-DEC-05 P.O. BOX 50457 510(k) SUMMARY AVAILABLE FROM FDA INDIANAPOLIS, IN 46250-0457 DEVICE: ROSSMAX NON-INVASIVE BLOOD PRESSURE MONITORS, MODELS S380, K350 ROSSMAX INTERNATIONAL LTD. 510(k) NO: K052727(TRADITIONAL) ATTN: YOLANDA LIN PHONE NO : 886 226 597888 12F., NO.189, KANG CHIEN RD. SE DECISION MADE: 16-DEC-05 TAIPEI, CHINA (TAIWAN) 114 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: NITOM LOCKING FACEBOW RUSSELL SAMUELS ORTHODONTIC DESIGN510(k) NO: K052553(TRADITIONAL) ATTN: RUSSELL HENRY ASHLEIGH SAMUPHONE NO : 004 415 09216480 7 CRICKET LANE SE DECISION MADE: 22-DEC-05 LOUGHBOROUGH, 510(k) SUMMARY AVAILABLE FROM FDA LEICESTERSHIRE, ENGLAND, UNITED KINGDOM LE11 3PD DEVICE: SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM SCANDIUS BIOMEDICAL, INC. 510(k) NO: K052810(TRADITIONAL) ATTN: ERIC BANNON PHONE NO : 978-486-4088 11A BEAVER BROOK ROAD SE DECISION MADE: 20-DEC-05 LITTLETON, MA 01460 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DR. SCHOLL'S DUAL ACTION FREEZE AWAY WART REMOVER, MODEL 40406 SCHERING-PLOUGH HEALTHCARE PRODUCT510(k) NO: K052259(TRADITIONAL) ATTN: DOREEN FRANK PHONE NO : 908-679-1655 3 CONNELL DR. SE DECISION MADE: 14-DEC-05 BERKELEY HEIGHTS, NJ 07922-0603 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SEASPINE VBR SYSTEM SEASPINE, INC. 510(k) NO: K052170(TRADITIONAL) ATTN: DIANA SMITH PHONE NO : 760-727-8399 2303 LA MIRADA DR. SE DECISION MADE: 21-DEC-05 VISTA, CA 92081-7862 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SEIN BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM, MODEL BGP- SEIN ELECTRONICS CO., LTD. 510(k) NO: K052108(ABBREVIATED) ATTN: JAY MANSOUR PHONE NO : 770-777-4146 1308 MORNINGSIDE PARK DRIVE SE DECISION MADE: 07-DEC-05 ALPHARETTA, GA 30022 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QMS QUINIDINE. QMS QUINIDINE CALIBRATORS SERADYN INC. 510(k) NO: K052826(TRADITIONAL) ATTN: JACK ROGERS PHONE NO : 317-610-3823 7998 GEORGETOWN RD. SE DECISION MADE: 23-DEC-05 SUITE 1000 510(k) SUMMARY AVAILABLE FROM FDA INDIANAPOLIS, IN 46268-5260 DEVICE: SERIM PERACETIC ACID CHEMICAL INDICATOR SERIM RESEARCH CORP. 510(k) NO: K052388(TRADITIONAL) ATTN: PATRICIA A RUPCHOCK PHONE NO : 574-264-3440 23565 REEDY DR. SE DECISION MADE: 01-DEC-05 ELKHART, IN 46514 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING S SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K053346(SPECIAL) ATTN: SUSAN D GOLSTEIN-FALK PHONE NO : 480-451-7502 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 09-DEC-05 GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FOX PULSE OXIMETER SHUNSUKE NAKANISHI 510(k) NO: K051736(TRADITIONAL) ATTN: YINGCHAO XIAO PHONE NO : 626-799-0998 2600 MISSION STREET, SUITE 100 SE DECISION MADE: 02-DEC-05 SAN MARIN0, CA 91108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNGO DYNAMICS, VERSION 5.0 SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K053133(TRADITIONAL) ATTN: JUDITH CAMPBELL PHONE NO : 610-448-4918 51 VALLEY STREAM PARKWAY, E-50 SE DECISION MADE: 05-DEC-05 MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SKYLARK URO PROBE SKYLARK DEVICE & SYSTEMS CO., LTD 510(k) NO: K053007(TRADITIONAL) ATTN: GEORGE CHIANG PHONE NO : 886 335 87677 4F, 34, SEC. 3, SE DECISION MADE: 05-DEC-05 CHUNG SHAN NORTH RD. 510(k) SUMMARY AVAILABLE FROM FDA TAIPEI, CHINA (TAIWAN) 104 DEVICE: SMITH & NEPHEW COMPETITOR DUO KNEE FEMORAL SMITH & NEPHEW, INC. 510(k) NO: K052265(ABBREVIATED) ATTN: GINO J ROUSS PHONE NO : 901-399-6707 1450 BROOKS RD. SE DECISION MADE: 27-DEC-05 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMITH & NEPHEW PLATFORM HIP STEM SMITH & NEPHEW, INC. 510(k) NO: K052275(ABBREVIATED) ATTN: GINO ROUSS PHONE NO : 901-399-6707 1450 BROOKS RD. SE DECISION MADE: 07-DEC-05 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMITH & NEPHEW MODULAR HIP SMITH & NEPHEW, INC. 510(k) NO: K052426(ABBREVIATED) ATTN: JASON SELLS PHONE NO : 901-399-5520 1450 E BROOKS ROAD SE DECISION MADE: 07-DEC-05 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMBIT PUSH & PLAY AMBULATORY INFUSION PUMP SORENSON MEDICAL, INC. 510(k) NO: K052221(ABBREVIATED) ATTN: DOUGLAS BUESCHEL PHONE NO : 801-352-6267 1375 WEST 8040 SOUTH SE DECISION MADE: 08-DEC-05 WEST JORDAN, UT 84088-8320 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPECTRA HAIR REMOVAL LASER SPECTRAGENICS, INC. 510(k) NO: K052848(TRADITIONAL) ATTN: ROBERT E GROVE PHONE NO : 925-398-2049 5880 WEST LAS POSITAS BLVD. SE DECISION MADE: 27-DEC-05 SUITE 52 510(k) SUMMARY AVAILABLE FROM FDA PLEASANTON, CA 94588 DEVICE: POLYMER COATED ONLINE CHLORINATED POWDER FREE EXAMINATION GLOVES SPI GLOVES SDN. BHD. 510(k) NO: K050526(TRADITIONAL) ATTN: CHOOI FONG CHUN PHONE NO : 605 322 3200 5, PERSIARAN GREENTOWN 8 SE DECISION MADE: 06-DEC-05 GREENTOWN BUSINESS CENTER 510(k) SUMMARY AVAILABLE FROM FDA IPOH 30450, MALAYSIA DEVICE: SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER ST. JUDE MEDICAL 510(k) NO: K052644(SPECIAL) ATTN: GLENN JACQUES PHONE NO : 952-933-4700 14901 DEVEAU PL. SE DECISION MADE: 05-DEC-05 MINNETONKA, MN 55345-2126 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STAYHEALTHY BODY COMPOSITION ANALYZER, MODELS BC1 AND BC2 STAYHEALTHY, INC. 510(k) NO: K052522(TRADITIONAL) ATTN: COLIN K HILL PHONE NO : 626-215-6202 300 ELFWOOD DRIVE SE DECISION MADE: 13-DEC-05 MONROVIA, CA 91016 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRONUS GUIDEWIRE, MODEL 001-001470-1 STEREOTAXIS, INC. 510(k) NO: K051373(TRADITIONAL) ATTN: KELLY ROWLAND PHONE NO : 314-633-5022 4041 FOREST PARK AVE. SE DECISION MADE: 09-DEC-05 ST. LOUIS, MO 63108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERIFY SYSTEM 1 BIOLOGICAL MONITORING KIT STERIS CORPORATION 510(k) NO: K053249(SPECIAL) ATTN: CYNTHIA J.M. NOLTE PHONE NO : 919-859-4207 49 PLAIN STREET SE DECISION MADE: 15-DEC-05 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEART STG SYSTEM AND SOFTWARE STETHOGRAPHICS, INC. 510(k) NO: K052283(TRADITIONAL) ATTN: ROZANNE PACIEJ PHONE NO : 617-983-7259 1153 CENTRE STREET SE DECISION MADE: 23-DEC-05 BOSTON, MA 02130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRYKER CUSTOM TI IMPLANT STRYKER LEIBINGER 510(k) NO: K052871(TRADITIONAL) ATTN: WADE T RUTKOSKIE PHONE NO : 269-323-4226 4100 EAST MILHAM AVE. SE DECISION MADE: 16-DEC-05 KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRYKER INJECTABLE CEMENT STRYKER LEIBINGER MICRO IMPLANTS 510(k) NO: K051603(TRADITIONAL) ATTN: WADE T RUTKOSKIE PHONE NO : 877-534-2464 750 TRADE CENTRE WAY SE DECISION MADE: 30-DEC-05 PORTAGE, MI 49002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XIA SPINAL SYSTEM STRYKER SPINE 510(k) NO: K053115(SPECIAL) ATTN: SIMONA VOIC PHONE NO : 201-760-8145 2 PEARL COURT SE DECISION MADE: 06-DEC-05 ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROSTIM REUSABLE NEUROSTIMULATION ELECTRODES SUMMIT MANUFACTURING, L.L.C. 510(k) NO: K052875(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 27-DEC-05 GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTIMIZED BARB DESIGN SURGICAL SPECIALTIES CORP. 510(k) NO: K052962(TRADITIONAL) ATTN: ELIZABETH LAZARO PHONE NO : 610-404-1000 100 DENNIS DR. SE DECISION MADE: 06-DEC-05 READING, PA 19606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUPERSTITCH GW, MODELS 06-15-04-GW, 08-15-04-GW SUTURA, INC. 510(k) NO: K053482(SPECIAL) ATTN: GERARD J PRUD'HOMME PHONE NO : 202-637-5600 555 THIRTEENTH ST. NW SE DECISION MADE: 27-DEC-05 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DDRFORMULA AND DDRFORMULA PLUS SWISSRAY MEDICAL AG 510(k) NO: K052943(TRADITIONAL) ATTN: JOHN MONAHAN PHONE NO : 908-353-0971 1180 MCLESTER STREET, UNIT #2 SE DECISION MADE: 15-DEC-05 ELIZABETH, NJ 07201 510(k) STATEMENT DEVICE: SYNTHES (USA) STERNAL FIXATION SYSTEM SYNTHES (USA) 510(k) NO: K052683(SPECIAL) ATTN: LISA BOYLE PHONE NO : 610-719-5861 1302 WRIGHTS LANE EAST SE DECISION MADE: 05-DEC-05 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP SYNTHES (USA) 510(k) NO: K053105(TRADITIONAL) ATTN: LISA M BOYLE PHONE NO : 610-719-5861 1302 WRIGHTS LANE EAST SE DECISION MADE: 02-DEC-05 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANT SYNTHES (USA) 510(k) NO: K053199(SPECIAL) ATTN: LISA BOYLE PHONE NO : 610-719-5861 1302 WRIGHTS LANE EAST SE DECISION MADE: 14-DEC-05 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES PANGEA MONOAXIAL SYSTEM SYNTHES SPINE CO.LP 510(k) NO: K052151(TRADITIONAL) ATTN: ANGELA MIKROULIS PHONE NO : 610-719-5718 1302 WRIGHTS LANE EAST SE DECISION MADE: 07-DEC-05 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: A & I PEDIATRIC WHEELCHAIRS, MODELS RWAL2006-12, LT3207-12. A & TAIWAN AN I CO.,LTD. 510(k) NO: K052586(TRADITIONAL) ATTN: KEVIN WALLS PHONE NO : 720-962-5412 13 RED FOX LANE SE DECISION MADE: 09-DEC-05 LITTLETON, CO 80127 510(k) STATEMENT DEVICE: TECO ISE REAGENT SET FOR CX SYSTEM TECO DIAGNOSTICS 510(k) NO: K052724(TRADITIONAL) ATTN: JIAN VAECHES PHONE NO : 714-693-7788 1268 NORTH LAKEVIEW AVE. SE DECISION MADE: 14-DEC-05 ANAHEIM, CA 92807 510(k) STATEMENT DEVICE: TEH LOONG POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, Y TEH LOONG CORP. 510(k) NO: K052635(TRADITIONAL) ATTN: CHIEN LIN PHONE NO : 773-327-2054 2631, N. MAGNOLIA STREET SE DECISION MADE: 13-DEC-05 CHICAGO, IL 60614 510(k) STATEMENT DEVICE: SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD), M TERUMO EUROPE N.V. 510(k) NO: K052887(TRADITIONAL) ATTN: M.J. AERTS PHONE NO : 003 216 381211 RESEARCHPARK ZONE 2 SE DECISION MADE: 08-DEC-05 INTERLEUVENLAAN 40 510(k) SUMMARY AVAILABLE FROM FDA LEUVEN 3001, BELGIUM 3001 DEVICE: ANSPACH KNOTLESS ANCHOR THE ANSPACH EFFORT, INC. 510(k) NO: K052572(TRADITIONAL) ATTN: WILLIAM CONETY PHONE NO : 561-627-1080 4500 RIVERSIDE DR. SE DECISION MADE: 05-DEC-05 PALM BEACH GARDENS, FL 33410 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LMA FASTRACH ETT SINGLE USE THE LARYNGEAL MASK CO.,LTD. 510(k) NO: K051993(TRADITIONAL) ATTN: FOSTER BOOP PHONE NO : 858-622-5621 9360 TOWNE CENTRE DR. SE DECISION MADE: 13-DEC-05 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAGSTIM RAPID2, MAGSTIM SUPER RAPID2, MODELS 3004-000, 3005-00 THE MAGSTIM COMPANY LTD. 510(k) NO: K051864(TRADITIONAL) ATTN: ANTHONY THOMAS PHONE NO : 441 994 242905 SPRING GARDENS SE DECISION MADE: 21-DEC-05 CARMARTHENSHIRE, WHALES, UNITED KI510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800 THE MAGSTIM COMPANY LTD. 510(k) NO: K053141(SPECIAL) ATTN: CHRIS LEWIS PHONE NO : 441 994 240798 SPRING GARDENS SE DECISION MADE: 14-DEC-05 WHITLAND, DYFED WALES, UNITED KING510(k) STATEMENT DEVICE: MODIFICATION TO THERMAGE THERMACOOL SYSTEM THERMAGE, INC. 510(k) NO: K053365(TRADITIONAL) ATTN: PAMELA M BUCKMAN PHONE NO : 510-782-2286 25881 INDUSTRIAL BLVD. SE DECISION MADE: 13-DEC-05 HAYWARD, CA 94545 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MYOTRAC INFINITI THOUGHT TECHNOLOGY LTD. 510(k) NO: K053266(TRADITIONAL) ATTN: SURESH SUGIRTHARAJA PHONE NO : 514 489 8251 2180 BELGRAVE AVE. SE DECISION MADE: 29-DEC-05 MONTREAL, QUEBEC, CANADA H4A 2LB 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: GLUCOSE PILOT TIANJIN NEW BAY BIORESEARCH CO., L510(k) NO: K052208(TRADITIONAL) ATTN: RODBRIGO BERLIE PHONE NO : 760-602-2929 3108 AVENIDA OLMEDA SE DECISION MADE: 09-DEC-05 CARLSBAD, CA 92009 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VAPORMAX II TRIMEDYNE, INC. 510(k) NO: K053457(TRADITIONAL) ATTN: GLENN D YEIK PHONE NO : 949-951-3800 15091 BAKE PKWY. SE DECISION MADE: 21-DEC-05 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: TYRX SURGICAL MESH, MODEL SMPC-0501 TYRX PHARMA INC 510(k) NO: K052864(TRADITIONAL) ATTN: MASON W DIAMOND PHONE NO : 732-246-8676 1 DEER PARK DR SE DECISION MADE: 22-DEC-05 SUITE G 510(k) SUMMARY AVAILABLE FROM FDA MONMOUTH JUNCTION, NJ 08852 DEVICE: TANGORS POLYAXIAL SYSTEM ULRICH GMBH & CO. KG 510(k) NO: K052385(TRADITIONAL) ATTN: CHRISTOPH ULRICH PHONE NO : 490 731 9654110 BUCHBRUNNENWEG 12 SE DECISION MADE: 27-DEC-05 ULM, GERMANY D-89081 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC UNIPATH LTD. 510(k) NO: K051638(TRADITIONAL) ATTN: LOUISE ROBERTS PHONE NO : 44 123 4835564 PRIORY BUSINESS PARK SE DECISION MADE: 06-DEC-05 BEDFORD, UNITED KINGDOM MK44 3UP 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIG DRAINAGE CATHETER URESIL, LLC 510(k) NO: K053245(SPECIAL) ATTN: MATTHEW MAHON PHONE NO : 847-982-0200 5418 WEST TOUHY AVE. SE DECISION MADE: 20-DEC-05 SKOKIE, IL 60077 510(k) STATEMENT DEVICE: VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES VANGUARD MEDICAL CONCEPTS, INC. 510(k) NO: K053051(TRADITIONAL) ATTN: TRISH STEPHENS PHONE NO : 863-683-8680 5307 GREAT OAK DR. SE DECISION MADE: 22-DEC-05 LAKELAND, FL 33815 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VASCULAR SOLUTIONS SKYWAY SUPPORT CATHETER VASCULAR SOLUTIONS, INC. 510(k) NO: K052258(TRADITIONAL) ATTN: SARA L COON PHONE NO : 763-656-4399 6464 SYCAMORE COURT NORTH SE DECISION MADE: 13-DEC-05 MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VAX-D GENESIS SYSTEM (THERAPEUTIC TABLE) VAX-D MEDICAL TECHNOLOGIES USA, L.510(k) NO: K053503(TRADITIONAL) ATTN: LAWRENCE DYER PHONE NO : 813-343-5000 310 MEARS BLVD. SE DECISION MADE: 28-DEC-05 OLDSMAR, FL 34677 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: INFUSIONCATH PERIPHERAL INFUSION CATHETER, MODELS VF0012, VF0016 VEINRX INC. 510(k) NO: K052738(SPECIAL) ATTN: GREGORY J MATHISON PHONE NO : 305-716-7005 8200 N.W. 27TH ST., STE. 102 SE DECISION MADE: 06-DEC-05 MIAMI, FL 33122 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITREA2 VERSION 3.8 MEDICAL IMAGE PROCESSING SOFTWARE VITAL IMAGES, INC. 510(k) NO: K052632(TRADITIONAL) ATTN: TIMOTHY J KAPPERS PHONE NO : 5850 OPUS PARKWAY, SE DECISION MADE: 15-DEC-05 SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA MINNETONKA, MN 55343-4414 THIRD PARTY REVIEW DEVICE: FUTURABOND NR SINGLE DOSE VOCO GMBH 510(k) NO: K053392(SPECIAL) ATTN: MICHAEL SUS PHONE NO : 490 472 1719214 ANTON-FLETTNER-STRASSE 1-3 SE DECISION MADE: 15-DEC-05 CUXHAVEN, GERMANY D-27472 510(k) STATEMENT DEVICE: IN VISION GOLD WITH SPIN VISION, MODEL 891 SV VOLCANO CORPORATION 510(k) NO: K052348(TRADITIONAL) ATTN: JENNIFER M MOTTO PHONE NO : 916-638-9430 2870 KILGORE RD. SE DECISION MADE: 02-DEC-05 RANCHO CORDOVA, CA 95670 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERILE EQUIPMENT COVERS VOLCANO CORPORATION 510(k) NO: K052395(TRADITIONAL) ATTN: MICHELLE J BADAL PHONE NO : 916-861-0287 2870 KILGORE RD. SE DECISION MADE: 01-DEC-05 RANCHO CORDOVA, CA 95670 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEXTROSCOPE & DEXTROBEAM VOLUME INTERACTIONS PTE LTD 510(k) NO: K053162(SPECIAL) ATTN: R. FAREETH PHONE NO : +65 622 26962 1 KIM SENG PROMENADE SE DECISION MADE: 09-DEC-05 #12-01 GREAT WORLD CITY EAST 510(k) STATEMENT TOWER, SINGAPORE, SINGAPORE 237994 DEVICE: GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL W.L. GORE & ASSOCIATES 510(k) NO: K053202(SPECIAL) ATTN: MICHAEL IVEY PHONE NO : 928-864-3790 3450 W. KILTE LANE SE DECISION MADE: 07-DEC-05 FLAGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL W.L. GORE & ASSOCIATES,INC 510(k) NO: K053200(SPECIAL) ATTN: MICHAEL IVEY PHONE NO : 928-864-3790 3750 W. KILTIE LN. SE DECISION MADE: 07-DEC-05 FLAGSTAFF, AZ 86001-0900 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, WAKO CHEMICALS, USA, INC. 510(k) NO: K053131(TRADITIONAL) ATTN: LORI CREASY PHONE NO : 804-714-1932 1600 BELLWOOD ROAD SE DECISION MADE: 30-DEC-05 RICHMOND, VA 23237 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, WAKO CHEMICALS, USA, INC. 510(k) NO: K053132(TRADITIONAL) ATTN: LORI CREASY PHONE NO : 804-714-1932 1600 BELLWOOD ROAD SE DECISION MADE: 30-DEC-05 RICHMOND, VA 23237 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUITY CENTRAL STATION, MODEL 020XXXXX (NOTE: XXXXX = VARIOUS C WELCH ALLYN, INC. 510(k) NO: K052160(ABBREVIATED) ATTN: JOHN E SAWYER PHONE NO : 315-685-4571 4341 STATE ST. RD. SE DECISION MADE: 16-DEC-05 SKANEATELES FALLS, NY 13153-0220 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WINNER SELF SEAL STERILIZATION POUCH WINNER MEDICAL (USA), INC. 510(k) NO: K051242(TRADITIONAL) ATTN: MING XIE PHONE NO : 909-996-9222 1900 PROFORMA AVE. #H SE DECISION MADE: 13-DEC-05 ONTARIO, CA 91761 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LINEAGE A-CLASS POLY LINER WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K052026(TRADITIONAL) ATTN: THERESA LEISTER PHONE NO : 901-867-4143 5677 AIRLINE RD. SE DECISION MADE: 05-DEC-05 ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAPLESS PEDICLE SCREW SYSTEM X-SPINE SYSTEMS, INC. 510(k) NO: K052847(TRADITIONAL) ATTN: FLOYD G LARSON PHONE NO : 858-792-1235 11234 EL CAMINO REAL SE DECISION MADE: 12-DEC-05 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA SAN DIEGO, CA 92130 DEVICE: AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM XOFT, INC. 510(k) NO: K050843(TRADITIONAL) ATTN: KATHY O'SHAUGHNESSY PHONE NO : 510-580-2900 49000 MILMONT DRIVE SE DECISION MADE: 22-DEC-05 FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZAN LUNG-FUNCTION LAB ZAN MESSGERATE GMBH 510(k) NO: K052328(TRADITIONAL) ATTN: JIM LEWIS PHONE NO : 303-666-5555 908 MAIN STREET SE DECISION MADE: 22-DEC-05 LOUISVILLE, CO 80027 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTEM. ZEUS SCIENTIFIC, INC. 510(k) NO: K051484(TRADITIONAL) ATTN: MARK K KOPNITSKY PHONE NO : 908-526-3744 200 EVANS WAY SE DECISION MADE: 05-DEC-05 BRANCHBURG, NJ 08876 510(k) STATEMENT DEVICE: YUSHENG DISPOSABLE VAGINAL SPECULUM ZHEJIANG YUSHENG MEDICAL INSTRUMEN510(k) NO: K052912(TRADITIONAL) ATTN: PEIFANG XING PHONE NO : 865 767 204617 XUANMEN INDUSTRIAL ZONE, LUPU SE DECISION MADE: 15-DEC-05 TOWN, YUHUAN COUNTY 510(k) STATEMENT ZHEJIANG PROVINCE, P.R., CHINA 317608 DEVICE: ZIMMER COMPUTER ASSISTED SOLUTIONS-ELECTROMAGNETIC AND IMAGELESS ZIMMER, INC. 510(k) NO: K052425(TRADITIONAL) ATTN: STEPHEN H MCKELVEY PHONE NO : 574-372-4944 P.O. BOX 708 SE DECISION MADE: 28-DEC-05 WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM ZIMMER, INC. 510(k) NO: K052906(TRADITIONAL) ATTN: DALENE T BINKLEY PHONE NO : 574-372-4907 P.O. BOX 708 SE DECISION MADE: 19-DEC-05 WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIES ZIMMER, INC. 510(k) NO: K053189(SPECIAL) ATTN: LAURA D WILLIAMS PHONE NO : 574-372-4523 P.O. BOX 708 SE DECISION MADE: 09-DEC-05 WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 290 TOTAL WITH SUMMARIES 254 TOTAL WITH STATEMENTS 36
Updated September 13, 2006
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