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Medical Devices
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December 2005 510(k) Clearances
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: K052160K051242(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
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