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510(k)s Final Decisions Rendered for July 2005 |
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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-JUL-2005 THROUGH 31-JUL-2005 DEVICE: 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 4100 3M COMPANY 510(k) NO: K051790(SPECIAL)
ATTN: GINGER CANTOR PHONE NO : 651-736-2101 3M CENTER, BLDG. 275-5W-06 SE DECISION MADE: 25-JUL-05 ST. PAUL, MN 55144-1000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FUTURE WASH/YPS 3M ESPE AG DENTAL PRODUCTS 510(k) NO: K051797(SPECIAL)
ATTN: ANDREAS PETERMANN PHONE NO : +49 815 27001395 ESPE PLATZ SE DECISION MADE: 21-JUL-05 SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3TP WORKSPACE 3TP LLC 510(k) NO: K050862(TRADITIONAL)
ATTN: MICHAEL KOCHIAN PHONE NO : 914-313-0352 245 MAIN ST., SUITE 620 SE DECISION MADE: 25-JUL-05 WHITE PLAINS, NY 10601 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM ABAXIS, INC. 510(k) NO: K051108(TRADITIONAL)
ATTN: DENNIS M BLEILE PHONE NO : 510-675-6515 3240 WHIPPLE RD. SE DECISION MADE: 08-JUL-05 UNION CITY, CA 94587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CELL-DYN SAPPHIRE SYSTEM ABBOTT LABORATORIES 510(k) NO: K051215(TRADITIONAL)
ATTN: MICHELLE ROEDING PHONE NO : 408-567-3781 5440 PATRICK HENRY DR. SE DECISION MADE: 21-JUL-05 SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACE SURGICALPLASTER CALCIUM SULFACE HEMIHYDRATE ACE SURGICAL SUPPLY CO., INC. 510(k) NO: K051381(TRADITIONAL)
ATTN: J. EDWARD CARCHIDI PHONE NO : 508-588-3100 1034 PEARL ST. SE DECISION MADE: 15-JUL-05 BROCKTON, MA 02301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUMED RIB CONGRIENT BONE PLATE SYSTEM ACUMED LLC 510(k) NO: K051410(TRADITIONAL)
ATTN: ED BOEHMER PHONE NO : 503-627-9957 5885 NW CORNELIUS PASS RD. SE DECISION MADE: 21-JUL-05 HILLSBORO, OR 97124-9432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LENS PLUS REWETTING DROPS ADVANCED MEDICAL OPTICS, INC. 510(k) NO: K042562(ABBREVIATED)
ATTN: PETER XU PHONE NO : 714-247-8592 1700 E. ST. ANDREW PLACE SE DECISION MADE: 29-JUL-05 P.O. BOX 25162 510(k) SUMMARY AVAILABLE FROM FDA SANTA ANA, CA 92705-4933 DEVICE: OMEGA EXCEL/XP LASER SYSTEM ADVANCED MEDICAL TECHNOLOGIES, INC510(k) NO: K043353(TRADITIONAL)
ATTN: M. JOYCE HEINRICH PHONE NO : 713-734-4433 12101 CULLEN BLVD., #A SE DECISION MADE: 01-JUL-05 HOUSTON, TX 77047 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: S4 SPINAL SYSTEM AESCULAP, INC. 510(k) NO: K050979(TRADITIONAL)
ATTN: JOYCE KILROY PHONE NO : 610-797-9300 3773 CORPORATE PKWY. SE DECISION MADE: 27-JUL-05 CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYDRALOK SYSTEM ALTIVA CORP. 510(k) NO: K051216(TRADITIONAL)
ATTN: JOHN KAPITAN PHONE NO : 704-409-1754 9800-I SOUTHERN PINE BLVD. SE DECISION MADE: 19-JUL-05 CHARLOTTE, NC 28273 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOVENTIONS ALIMAXX-E ESOPHAGEAL STENT SYSTEM ALVEOLUS, INC. 510(k) NO: K051621(TRADITIONAL)
ATTN: DONALD V CANAL PHONE NO : 704-926-4837 9013 PERIMETER WOODS SUITE A SE DECISION MADE: 11-JUL-05 CHARLOTTE, NC 28216 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RAPID READER AMERICAN BIO MEDICA CORP. 510(k) NO: K041696(TRADITIONAL)
ATTN: FRAN WHITE PHONE NO : 978-927-3808 163 CABOT ST. SE DECISION MADE: 12-JUL-05 BEVERLY, MA 01915 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MONARC + SUBFASCIAL HAMMOCK, MODEL 72404193; MONARC C SUBFASCIAL AMERICAN MEDICAL SYSTEMS, INC. 510(k) NO: K051530(SPECIAL)
ATTN: DENISE THOMPSON PHONE NO : 952-930-6489 10700 BREN RD., WEST SE DECISION MADE: 08-JUL-05 MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMSINO ENDOTRACHEAL TUBE AMSINO INTERNATIONAL, INC. 510(k) NO: K050785(TRADITIONAL)
ATTN: CHING CHING SEAH PHONE NO : 909-626-5888 855 TOWNE CENTER DRIVE SE DECISION MADE: 15-JUL-05 POMONA, CA 91767 510(k) STATEMENT DEVICE: ANGIODYNAMICS TUMESCENT INFUSION DEVICE ANGIODYNAMICS, INC. 510(k) NO: K051142(TRADITIONAL)
ATTN: TERI JUCKETT PHONE NO : 518-798-1215 603 QUEENSBURY AVE. SE DECISION MADE: 13-JUL-05 QUEENSBURY, NY 12804 510(k) STATEMENT DEVICE: INSTANT-X, MODELS 1713 & 128 ANN ARBOR DIGITAL DEVICES 510(k) NO: K042791(TRADITIONAL)
ATTN: WILLIAM J O'NEILL PHONE NO : 734-834-5156 699 SKYNOB COURT SE DECISION MADE: 01-JUL-05 ANN ARBOR, MI 48105 510(k) STATEMENT DEVICE: NOMAD DENTAL X-RAY SYSTEM ARIBEX, INC. 510(k) NO: K051795(TRADITIONAL)
ATTN: D.CLARK TURNER PHONE NO : 801-226-5522 754 SOUTH 400 EAST SE DECISION MADE: 14-JUL-05 OREM, UT 84097 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ENDOSSEOUS DENTAL IMPLANT ABUTMENT ATLANTIS COMPONENTS, INC. 510(k) NO: K051011(TRADITIONAL)
ATTN: BETSY A BROWN PHONE NO : 847-560-4406 8944 TAMAROA TERRACE SE DECISION MADE: 12-JUL-05 SKOKIE, IL 60076 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATLANTIS ABUTMENT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI+ AB ATLANTIS COMPONENTS, INC. 510(k) NO: K051652(TRADITIONAL)
ATTN: BETSY BROWN PHONE NO : 847-560-4406 8944 TAMAROA TERRACE SE DECISION MADE: 22-JUL-05 SKOKIE, IL 60076 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AXIOM EPS8000 AXIOM WORLDWIDE, INC. 510(k) NO: K050687(TRADITIONAL)
ATTN: JAMES J GIBSON PHONE NO : 813-249-6444 9423 CORPORATE LAKE DRIVE SE DECISION MADE: 28-JUL-05 TAMPA, FL 33634 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AFINION HBALC AXIS-SHIELD POC AS 510(k) NO: K050574(TRADITIONAL)
ATTN: RONALD G LEONARDI PHONE NO : 858-586-0751 P.O. BOX 262069 SE DECISION MADE: 22-JUL-05 SAN DIEGO, CA 92196 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANEFIN, MODEL 100 AXON MEDICAL 510(k) NO: K033028(TRADITIONAL)
ATTN: JOSEPH ORR PHONE NO : 801-484-3820 2355 SOUTH 1170 WEST SE DECISION MADE: 22-JUL-05 SUITE D 510(k) SUMMARY AVAILABLE FROM FDA SALT LAKE CITY, UT 84119 DEVICE: FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT BARD PERIPHERAL VASCULAR, INC. 510(k) NO: K050832(SPECIAL)
ATTN: DENNIS SALZMANN PHONE NO : 480-303-2780 P.O. BOX 1740 SE DECISION MADE: 07-JUL-05 TEMPE, AZ 85280-1740 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MU BAXTER HEALTHCARE CORP. 510(k) NO: K051253(TRADITIONAL)
ATTN: NANETTE HEDDEN PHONE NO : 847-473-6281 1620 WAUKEGAN ROAD SE DECISION MADE: 15-JUL-05 MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD ONECATH PERIPHERALLY INSERTED CENTRAL CATHETER, MODELS 384647 BECTON DICKINSON & CO. 510(k) NO: K051194(TRADITIONAL)
ATTN: LESLIE WOOD PHONE NO : 801-565-2504 9450 SOUTH STATE STREET SE DECISION MADE: 25-JUL-05 SANDY, UT 84070 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD DIRECTIGEN EZ FLU A + B BECTON, DICKINSON & CO. 510(k) NO: K042472(TRADITIONAL)
ATTN: MICHELLE BYTHEWAY BANDY PHONE NO : 410-316-4778 7 LOVETON CIR. SE DECISION MADE: 07-JUL-05 SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - LINEZOLID (STREP) 0.2 BECTON, DICKINSON & CO. 510(k) NO: K051266(TRADITIONAL)
ATTN: MONICA E GIGUERE PHONE NO : 410-316-4287 7 LOVETON CIR. SE DECISION MADE: 05-JUL-05 SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CLINDAMYCIN (STREP) 0 BECTON, DICKINSON & CO. 510(k) NO: K051272(TRADITIONAL)
ATTN: MONICA E GIGUERE PHONE NO : 410-316-4287 7 LOVETON CIR. SE DECISION MADE: 11-JUL-05 SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMOXICILLIN (STREP) 0 BECTON, DICKINSON & CO. 510(k) NO: K051692(TRADITIONAL)
ATTN: MONICA E GIGUERE PHONE NO : 410-316-4287 7 LOVETON CIR. SE DECISION MADE: 14-JUL-05 SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MARROW PLUS (M+) BERKELEY ADVANCED BIOMATERIALS, IN510(k) NO: K051695(TRADITIONAL)
ATTN: FRANCOIS GENIN PHONE NO : 510-883-0500 901 GRAYSON ST., SUITE 101 SE DECISION MADE: 19-JUL-05 BERKELEY, CA 94710 510(k) STATEMENT DEVICE: K-C HEMOSTATIC BIOPSY SYSTEM BIOENGINEERING CONSULTANTS LTD. 510(k) NO: K050135(TRADITIONAL)
ATTN: WILLIAM R KRAUSE PHONE NO : 434-979-4134 801 WEST MAIN STREET SE DECISION MADE: 13-JUL-05 CHARLOTTESVILLE, VA 22903 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RELIADENT DENTAL IMPLANT SYSTEM BIOINFERA, INC. 510(k) NO: K043428(ABBREVIATED)
ATTN: CHAN Q WANG PHONE NO : 216-225-2860 21205 HALWORTH ROAD SE DECISION MADE: 12-JUL-05 BEACHWOOD, OH 44122 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY KNEE PROSTHESES BIOMET, INC. 510(k) NO: K050210(TRADITIONAL)
ATTN: LONNIE WITHAM PHONE NO : 574-267-6639 56 EAST BELL DR. SE DECISION MADE: 19-JUL-05 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: THE BIOPLATE RESORBABLE ENDOBROW FIXATION SYSTEM BIOPLATE, INC. 510(k) NO: K051845(SPECIAL)
ATTN: JESUS T FARINAS PHONE NO : 310-815-2100 3643 LENAWEE AVE. SE DECISION MADE: 27-JUL-05 LOS ANGELES, CA 90016-4310 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ILAB ULTRASOUND IMAGING SYSTEM BOSTON SCIENTIFIC CORP. 510(k) NO: K051679(SPECIAL)
ATTN: ROBERT Z PHILLIPS PHONE NO : 510-624-2307 47201 LAKEVIEW BLVD. SE DECISION MADE: 14-JUL-05 FREMONT, CA 94537 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER C.R. BARD, INC. 510(k) NO: K051316(TRADITIONAL)
ATTN: JOHN C KNORPP PHONE NO : 770-784-6451 8195 INDUSTRIAL BLVD. SE DECISION MADE: 18-JUL-05 COVINGTON, GA 30014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CANDELA FAMILY OF PULSED DYE LASER SYSTEMS: PIGMENTED LESION HAN CANDELA CORP. 510(k) NO: K051359(TRADITIONAL)
ATTN: LORRAINE CALZETTA PATROVIC PHONE NO : 508-358-7637 530 BOSTON POST RD. SE DECISION MADE: 13-JUL-05 WAYLAND, MA 01778 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PMP4 MEDICAL WEB CENTER CARD GUARD SCIENTIFIC SURVIVAL, LT510(k) NO: K050940(TRADITIONAL)
ATTN: ALEX GONOROVSKY PHONE NO : 972 894 84600 2 PERERIS ST., SCIENCE PARK SE DECISION MADE: 01-JUL-05 REHOVOT, ISRAEL 76100 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORONARY SINUS ACCESS KIT, MODEL KCS8F-01 CARDIO-OPTICS, INC. 510(k) NO: K050808(TRADITIONAL)
ATTN: LARRY BLANKENSHIP PHONE NO : 720-406-1560 2477 55TH ST., SUITE 120 SE DECISION MADE: 28-JUL-05 BOULDER, CO 80301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DERMILLUME RED, MODEL HR1000 CARE ELECTRONICS, INC. 510(k) NO: K051681(TRADITIONAL)
ATTN: THOMAS O MOODY PHONE NO : 303-444-2273 4700 STERLING DR., SUITE D SE DECISION MADE: 27-JUL-05 BOULDER, CO 80301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDSTAR 220, MODEL 533-220; MEDSTAR 230, MODEL 533-230; MEDSTAR CIBERNET SYSTEMS CORP. 510(k) NO: K050951(TRADITIONAL)
ATTN: ERIC LICHTENSTEIN PHONE NO : 734-668-2567 727 AIRPORT BOULEVARD SE DECISION MADE: 19-JUL-05 ANN ARBOR, MI 48108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED RELOADABLE CUTTERS, STAPLERS, AND APPLIERS CLEAR MEDICAL, INC. 510(k) NO: K033578(TRADITIONAL)
ATTN: MIKE KOVACS PHONE NO : 425-401-1414 1776 136TH PL. NE SE DECISION MADE: 11-JUL-05 BELLEVUE, WA 98005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED MULTIPLE CLIP APPLIERS CLEAR MEDICAL, INC. 510(k) NO: K033579(TRADITIONAL)
ATTN: MIKE KOVACS PHONE NO : 425-401-1414 1776 136TH PL. NE SE DECISION MADE: 11-JUL-05 BELLEVUE, WA 98005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CODMAN VPV SYSTEM, MODEL 82-3192 CODMAN & SHURTLEFF, INC. 510(k) NO: K050739(TRADITIONAL)
ATTN: KAREN F JURCZAK PHONE NO : 508-828-3704 325 PARAMOUNT DR. SE DECISION MADE: 18-JUL-05 RAYNHAM, MA 02767-0350 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONMED IRRIGATION NOZZLE CONMED CORP. 510(k) NO: K050992(TRADITIONAL)
ATTN: IRA DUESLER PHONE NO : 315-624-3072 525 FRENCH RD. SE DECISION MADE: 14-JUL-05 UTICA, NY 13502 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TURBO-FLO PICC COOK, INC. 510(k) NO: K041849(TRADITIONAL)
ATTN: EARL E KNIGHT III PHONE NO : 812-339-2235 750 DANIELS WAY PO BX 489 SE DECISION MADE: 21-JUL-05 BLOOMINGTON, IN 47402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZILVER 635 BILIARY STENT COOK, INC. 510(k) NO: K051124(SPECIAL)
ATTN: STEPHANIE ROBERTS PHONE NO : 800-346-2686 750 DANIELS WAY PO BX 489 SE DECISION MADE: 12-JUL-05 BLOOMINGTON, IN 47402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALLFIM IMPLANT SYSTEMS COWELL MEDI CO LTD. 510(k) NO: K050635(TRADITIONAL)
ATTN: DAE KYU CHANG PHONE NO : 562-404-8466 13340 E. FIRESTONE BLVD. SE DECISION MADE: 28-JUL-05 SUITES J 510(k) SUMMARY AVAILABLE FROM FDA SANTA FE SPRINGS, CA 90670 DEVICE: CS MEDICAL ADULT TTCF CATHETER CS MEDICAL INC. 510(k) NO: K050379(TRADITIONAL)
ATTN: LEWIS WARD PHONE NO : 303-530-3279 4655 KIRKWOOD COURT SE DECISION MADE: 12-JUL-05 BOULDER, CO 80301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CS MEDICAL TTCF GAS DELIVERY SYSTEM CS MEDICAL INC. 510(k) NO: K050381(TRADITIONAL)
ATTN: LEWIS WARD PHONE NO : 303-530-3279 4655 KIRKWOOD COURT SE DECISION MADE: 13-JUL-05 BOULDER, CO 80301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CERASORB DENTAL, CERASORB M DENTAL AND CERASORB PERIO CURASAN AG, FRANKFURT FACILITY 510(k) NO: K051443(ABBREVIATED)
ATTN: ERIC WIECHERT PHONE NO : 919-772-8518 109 SHORE DRIVE SE DECISION MADE: 22-JUL-05 GARNER, NC 27529 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMARTECH, MODEL HOLI I CYCLING AND HEALTH TECH. INDUSTRY 510(k) NO: K050507(TRADITIONAL)
ATTN: CHANG WAN-LAN PHONE NO : 886 4 23501100 NO. 17, 37TH RD. SE DECISION MADE: 07-JUL-05 TAICHUNG INDUSTRY PARK 510(k) SUMMARY AVAILABLE FROM FDA TAICHUNG, CHINA (TAIWAN) 40768 DEVICE: LANDLEX MODEL S400X CYCLING AND HEALTH TECH. INDUSTRY 510(k) NO: K050793(TRADITIONAL)
ATTN: CHANG WAN-LAN PHONE NO : 886 4 23501100 NO. 17, 37TH RD. SE DECISION MADE: 07-JUL-05 TAICHUNG INDUSTRY PARK 510(k) SUMMARY AVAILABLE FROM FDA TAICHUNG, CHINA (TAIWAN) 40768 DEVICE: DIMENSION VISTA INTEGRATED SYSTEM DADE BEHRING, INC. 510(k) NO: K051087(TRADITIONAL)
ATTN: LORRAINE H PIESTRAK PHONE NO : 302-631-6279 P.O. BOX 6101 BLDG 500;M.S.514 SE DECISION MADE: 11-JUL-05 NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROSCAN SYNERGIES PLUS GRAM POSITIVE MINIMUM INHIBITORY CONCEN DADE BEHRING, INC. 510(k) NO: K051311(TRADITIONAL)
ATTN: ROBERT EUSEBIO PHONE NO : 916-374-3183 1584 ENTERPRISE BLVD. SE DECISION MADE: 12-JUL-05 WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS DADE BEHRING, INC. 510(k) NO: K051350(TRADITIONAL)
ATTN: ROBERTO EUSEBIO PHONE NO : 916-372-1900 2040 ENTERPRISE BLVD. SE DECISION MADE: 25-JUL-05 WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS - RIFAMP DADE BEHRING, INC. 510(k) NO: K051478(TRADITIONAL)
ATTN: ROBERT EUSEBIO PHONE NO : 916-374-3183 1584 ENTERPRISE BLVD. SE DECISION MADE: 27-JUL-05 WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: READMYHEART, MODEL RMH3.0 DAILYCARE BIOMEDICAL INC 510(k) NO: K050620(TRADITIONAL)
ATTN: DANIEL J CHANG PHONE NO : 886 3 2621688 8F, 25-3 JI-LIN ROAD SE DECISION MADE: 14-JUL-05 CHUNGLI, CHINA (TAIWAN) 320 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XENO ADHESIVE WITH ACTIVATOR DENTSPLY INTL. 510(k) NO: K051463(TRADITIONAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511 221 WEST PHILADELPHIA STREET SE DECISION MADE: 12-JUL-05 SUITE 60 510(k) SUMMARY AVAILABLE FROM FDA YORK, PA 17404 DEVICE: ECLIPSE BONDING AGENT DENTSPLY INTL. 510(k) NO: K051707(SPECIAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511 221 WEST PHILADELPHIA STREET SE DECISION MADE: 15-JUL-05 SUITE 60 510(k) SUMMARY AVAILABLE FROM FDA YORK, PA 17404 DEVICE: THE ODFS DROPPED FOOT STIMULATOR DEPARTMENT OF MEDICAL PHYSICS AND 510(k) NO: K050991(TRADITIONAL)
ATTN: TINA LECHMAN PHONE NO : 216-378-9106 ONE CHAGRIN HIGHLANDS SE DECISION MADE: 15-JUL-05 2000 AUBURN DRIVE, SUITE 320 510(k) SUMMARY AVAILABLE FROM FDA CLEVELAND, OH 44122 DEVICE: EXPEDIUM SPINE SYSTEM DEPUY SPINE, INC. 510(k) NO: K051024(SPECIAL)
ATTN: SHARON STAROWICZ PHONE NO : 508-828-2867 325 PARAMOUNT DR. SE DECISION MADE: 06-JUL-05 RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERTEBROPLASTIC RADIOPAQUE BONE CEMENT DEPUY SPINE,INC 510(k) NO: K043406(TRADITIONAL)
ATTN: SHARON STAROWICZ PHONE NO : 508-828-2867 325 PARAMONT DRIVE SE DECISION MADE: 15-JUL-05 RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DCL MICROALBUMIN ASSAY, MODEL 252-20 DIAGNOSTIC CHEMICALS LTD. 510(k) NO: K051191(TRADITIONAL)
ATTN: PENNY WHITE PHONE NO : 902 566 1396 16 MCCARVILLE ST. SE DECISION MADE: 05-JUL-05 CHARLOTTETOWN, P.E.I., CANADA C1E 510(k) STATEMENT DEVICE: CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM DIGIRAD CORP. 510(k) NO: K051549(SPECIAL)
ATTN: JOEL TUCKEY PHONE NO : 858-726-1600 13950 STOWE DRIVE SE DECISION MADE: 13-JUL-05 POWAY, CA 92064-8803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROTEGE ULTRASONIC INSERT DISCUS DENTAL INC. 510(k) NO: K051776(TRADITIONAL)
ATTN: SUZANNE RIDGWAY PHONE NO : 310-845-8339 8550 HIGUERA ST. SE DECISION MADE: 13-JUL-05 CULVER CITY, CA 90232 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: SKYLIGHT LED CURING LIGHT DMETEC CO., LTD. 510(k) NO: K051571(TRADITIONAL)
ATTN: CAROLANN KOTULA PHONE NO : 770-985-8203 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 19-JUL-05 GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JAUNDICE METER, MODEL JM 103 DRAEGER MEDICAL INFANT CARE, INC. 510(k) NO: K042522(TRADITIONAL)
ATTN: THOMAS M MCINTOSH PHONE NO : 215-682-8634 330 JACKSONVILLE RD. SE DECISION MADE: 06-JUL-05 HATBORO, PA 19040 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INFINITY MONITORS WITH SCIO MODIFICATIONS DRAEGER MEDICAL SYSTEMS, INC. 510(k) NO: K051628(SPECIAL)
ATTN: PENELOPE H GRECO PHONE NO : 978-907-7500 16 ELECTRONICS AVE. SE DECISION MADE: 20-JUL-05 DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EVITAXL WITH OPTION SMARTCARE DRAGER MEDICAL AG & CO. KGAA 510(k) NO: K051263(TRADITIONAL)
ATTN: MONICA FERRANTE PHONE NO : 215-721-5400 3135 QUARRY ROAD SE DECISION MADE: 12-JUL-05 TELFORD, PA 18969 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DYNATRON X3 , DYNATRON XP IR LIGHT PAD, D405 IR LIGHT PROBE DYNATRONICS CORP. 510(k) NO: K051261(TRADITIONAL)
ATTN: RONALD J HATCH PHONE NO : 801-568-7000 7030 PARK CENTRE DR. SE DECISION MADE: 25-JUL-05 SALT LAKE CITY, UT 84121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUMEN IMAGE GUIDED SURGICAL SYSTEM EBI, L.P. 510(k) NO: K051724(TRADITIONAL)
ATTN: WHITNEY TORNING PHONE NO : 973-299-9300 100 INTERPACE PKWY. SE DECISION MADE: 19-JUL-05 PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELEKTA ESARTE FRAME SYSTEM ELEKTA INSTRUMENT AB 510(k) NO: K051746(SPECIAL)
ATTN: PETER LOWENDAHL PHONE NO : 011 468 58725400 KUNGSTENSGATAN 18 SE DECISION MADE: 25-JUL-05 P.O.BOX 7593 510(k) SUMMARY AVAILABLE FROM FDA STOCKHOLM, SWEDEN S-103 93 DEVICE: COMPRESSOR NEBULIZER, MODEL EMG NBA02-XXX SERIES EMG TECHNOLOGY CO., LTD. 510(k) NO: K043238(ABBREVIATED)
ATTN: LEONARD FRIER PHONE NO : 410-354-3300 914 WEST PATAPSCO AVE. SE DECISION MADE: 06-JUL-05 BALTIMORE, MD 21230 510(k) STATEMENT DEVICE: ERBE ERBOKRYO CA CRYOSURGICAL UNIT & ACCESSORIES ERBE USA, INC. 510(k) NO: K051509(TRADITIONAL)
ATTN: JULIE STEPHENS PHONE NO : 678-513-0693 111 LAUREL RIDGE DRIVE SE DECISION MADE: 27-JUL-05 ALPHARETTA, GA 30004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MYLAB 90 ULTRASOUND IMAGING SYSTEM, MODEL 6100 ESAOTE, S.P.A. 510(k) NO: K051837(TRADITIONAL)
ATTN: CARRI GRAHAM PHONE NO : 317-849-1916 7992 CASTLEWAY DRIVE SE DECISION MADE: 20-JUL-05 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TERRAQUANT MQ2000 LASER THERAPY DEVICE ESCADA INTERNATIONAL, INC. 510(k) NO: K043055(TRADITIONAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 25-JUL-05 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: T-PLATE ANTERIOR FIXATION SYSTEM ESM TECHNOLOGIES 510(k) NO: K051764(TRADITIONAL)
ATTN: CLIFF TRIBUS PHONE NO : 608-332-8521 403 FARWELL DRIVE SE DECISION MADE: 13-JUL-05 MADISON, WI 53704 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEALIGHT IPL EUROPRO, INC. 510(k) NO: K043032(TRADITIONAL)
ATTN: GREG KENNEBECK PHONE NO : 800-272-1716 3952 CAMINO RANCHERO RD. SE DECISION MADE: 19-JUL-05 CAMARILLO, CA 93012 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOPAD EURORESEARCH S.R.L. 510(k) NO: K040283(TRADITIONAL)
ATTN: E. SMITH PHONE NO : 410-451-0639 1468 HARWELL AVENUE SE DECISION MADE: 22-JUL-05 CROFTON, MD 21114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSPIRATION VENTILATOR SYSTEM EVENT MEDICAL LTD. 510(k) NO: K051550(SPECIAL)
ATTN: ROBBIE WALSH PHONE NO : 353 917 64472 6A LIOSBAN BUSINESS PARK SE DECISION MADE: 12-JUL-05 TUAM ROAD 510(k) SUMMARY AVAILABLE FROM FDA GALWAY, IRELAND DEVICE: DISPOSABLE POWDER FREE VINYL EXAM GLOVE YELLOW COLOR EVER GLOBAL ENTERPRISE CORPORATION510(k) NO: K051393(ABBREVIATED)
ATTN: NICK BIEN PHONE NO : 886 266 003630 LONG THANH INDUSTRIAL ZONE SE DECISION MADE: 27-JUL-05 TAMAN VILLAGE, LONG THANH 510(k) SUMMARY AVAILABLE FROM FDA DIST., DONG NAI PROVINCE, VIETNAM DEVICE: DISPOSABLE POWDERED VINYL EXAM GLOVE YELLOW COLOR EVER GLOBAL ENTERPRISE CORPORATION510(k) NO: K051498(TRADITIONAL)
ATTN: NICK BIEN PHONE NO : 886 266 003630 LONG THANH INDUSTRIAL ZONE SE DECISION MADE: 06-JUL-05 TAMAN VILLAGE, LONG THANH 510(k) SUMMARY AVAILABLE FROM FDA DIST., DONG NAI PROVINCE, VIETNAM DEVICE: EXACTECH 12/14 ALUMINA FEMORAL HEADS 36 MM EXACTECH, INC. 510(k) NO: K051682(SPECIAL)
ATTN: MARITZA ELIAS PHONE NO : 352-377-1140 2320 N.W. 66TH CT. SE DECISION MADE: 19-JUL-05 GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FEMTEX AND PRIVATE LABEL OPAL FRESH SCENTED PLASTIC APPLICATOR T FIRST QUALITY HYGIENIC INC. 510(k) NO: K051446(TRADITIONAL)
ATTN: ROBERT J STAAB PHONE NO : 201-327-0035 73 FRANKLIN TPK SE DECISION MADE: 14-JUL-05 ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VP WIRE GW140ST (.014" 165CM, STANDAR), MODEL GW140ST; VP WIRE G FLOWCARDIA, INC. 510(k) NO: K051062(TRADITIONAL)
ATTN: RICHARD SPANO PHONE NO : 408-617-0352 745 N. PASTORIA AVE. SE DECISION MADE: 15-JUL-05 SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FUJI SYNAPSE WORKSTATION SOFTWARE FUJIFILM MEDICAL SYSTEMS USA, INC.510(k) NO: K051553(TRADITIONAL)
ATTN: ROBERT BERRY PHONE NO : 203-602-3753 419 WEST AVENUE SE DECISION MADE: 07-JUL-05 STAMFORD, CT 06902 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: NATURE-CRYL HI PLUS GC AMERICA, INC. 510(k) NO: K051358(TRADITIONAL)
ATTN: TERRY L JORITZ PHONE NO : 708-926-3105 3737 WEST 127TH ST. SE DECISION MADE: 07-JUL-05 ALSIP, IL 60803 510(k) STATEMENT DEVICE: DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION GE HEALTHCARE 510(k) NO: K051634(SPECIAL)
ATTN: JOEL C KENT PHONE NO : 781-449-8685 86 PILGRIM ROAD SE DECISION MADE: 19-JUL-05 NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DATEX-OHMEDA S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT AND AC GE HEALTHCARE 510(k) NO: K051635(SPECIAL)
ATTN: JOEL C KENT PHONE NO : 781-449-8685 86 PILGRIM ROAD SE DECISION MADE: 15-JUL-05 NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XELERIS 2 PROCESSING AND REVIEW WORKSTATION GE MEDICAL SYSTEMS 510(k) NO: K051673(SPECIAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894 3000 N GRANDVIEW BLVD. SE DECISION MADE: 18-JUL-05 W-709 510(k) SUMMARY AVAILABLE FROM FDA WAUKESHA, WI 53188 DEVICE: MARS HOLTER ANALYSIS WORKSTATION GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K051026(TRADITIONAL)
ATTN: LISA M BAUMHARDT PHONE NO : 262-293-1699 8200 WEST TOWER AVE. SE DECISION MADE: 19-JUL-05 MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNITY NETWORK ID GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K051518(SPECIAL)
ATTN: RONALD N BLASKI PHONE NO : 414-362-2348 8200 WEST TOWER AVE. SE DECISION MADE: 08-JUL-05 MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE OEC EVERVIEW 7500 GE OEC MEDICAL SYSTEMS, INC. 510(k) NO: K051490(TRADITIONAL)
ATTN: SUSAN SCHMIDT PHONE NO : 801-328-9300 384 WRIGHT BROTHERS DR. SE DECISION MADE: 07-JUL-05 SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SEPRAGEL ENT BIORESORBABLE PACKING/STENT GENZYME CORPORATION 510(k) NO: K043035(TRADITIONAL)
ATTN: BARBARA PIZZA PHONE NO : 617-252-7953 55 CAMBRIDGE PARKWAY SE DECISION MADE: 11-JUL-05 CAMBRIDGE, MA 02142 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDIOMEM CM 3000-12 GETEMED MEDIZIN- UND INFORMATIONST510(k) NO: K051686(ABBREVIATED)
ATTN: CAROLANN KOTULA PHONE NO : 770-985-8203 55 NORTHERN BLVD SE DECISION MADE: 14-JUL-05 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA GREAT NECK, NY 11021 DEVICE: PROTEX CT CERVICOTHORACIC SPINAL SYSTEM GLOBUS MEDICAL, INC. 510(k) NO: K050391(TRADITIONAL)
ATTN: KELLY J BAKER PHONE NO : 610-415-9000 303 SCHELL LANE SE DECISION MADE: 21-JUL-05 PHOENIXVILLE, PA 19460 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE ART OF INTIMACY RESPONSE PERSONAL LUBRICANT GOODMARK USA, INC. 510(k) NO: K051668(TRADITIONAL)
ATTN: ROBERT J MICHALIK PHONE NO : 12 BLENDON WOODS DRIVE SE DECISION MADE: 08-JUL-05 SOUTHBOROUGH, MA 01772 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: VINYL NITRILE CO-POLYMER POWDER FREE EXAM GLOVES (BLUE COLOR) GRAND WORK PLASTIC PRODUCTS CO., L510(k) NO: K051662(TRADITIONAL)
ATTN: MICKY LIN PHONE NO : 909-591-7888 3973 SCHAFER AVE. SE DECISION MADE: 22-JUL-05 CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLARIS NON-STICK BIPOLAR FORCEPS GUENTER BISSINGER MEDIZINTECHNIK G510(k) NO: K051429(TRADITIONAL)
ATTN: CHRISTA HEITMANN-FRANKE PHONE NO : 602-758-1029 ONE PARK AVE., SUITE #5G SE DECISION MADE: 29-JUL-05 HAMPTON, NH 03842 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MIRAMATIC SAFE SYRINGE SYSTEM HAGER WORLDWIDE, INC. 510(k) NO: K043322(TRADITIONAL)
ATTN: JAMES DELANEY PHONE NO : 978-475-5692 4 LINCOLN ST SE DECISION MADE: 21-JUL-05 ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO SHOULDER FIXATION SYSTEM HAND INNOVATIONS, LLC. 510(k) NO: K051728(SPECIAL)
ATTN: ERNESTO HERNANDEZ PHONE NO : 305-270-6899 8905 SW 87TH AVENUE SE DECISION MADE: 20-JUL-05 SUITE 220 510(k) SUMMARY AVAILABLE FROM FDA MIAMI, FL 33176 DEVICE: HANS HERMANN LAPAROSCOPES AND ACCESSORIES HANS HERMANN GMBH 510(k) NO: K051610(TRADITIONAL)
ATTN: HARALD JUNG PHONE NO : 49 746 1969236 UNTERER WINKEL 3 SE DECISION MADE: 29-JUL-05 WURMLINGEN, GERMANY D-78567 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: BOSWORTH SEAL HARRY J. BOSWORTH CO. 510(k) NO: K051224(TRADITIONAL)
ATTN: MILDRED M GOLDSTEIN PHONE NO : 847-679-3400 7227 NORTH HAMLIN AVE. SE DECISION MADE: 28-JUL-05 SKOKIE, IL 60076 510(k) STATEMENT DEVICE: NITRILE POWDERED EXAMINATION GLOVES (BLUE) HARTALEGA SDN BHD 510(k) NO: K051778(TRADITIONAL)
ATTN: KUAN KAM HON PHONE NO : 603 627 42177 9 JALAN KUANG BULAN TAMAN SE DECISION MADE: 26-JUL-05 KEPONG INDUSTRIAL ESTATE 510(k) STATEMENT KUALA LUMPUR, MALAYSIA 52100 DEVICE: HEMORAM/AGGRAM ANALYZER HELENA LABORATORIES 510(k) NO: K050053(TRADITIONAL)
ATTN: PATRICIA FRANKS PHONE NO : 409-842-3714 1530 LINDBERGH DR. SE DECISION MADE: 11-JUL-05 P.O. BOX 752 510(k) STATEMENT BEAUMONT, TX 77704 DEVICE: PALACOS LV+G HERAEUS KULZER GMBH 510(k) NO: K050854(TRADITIONAL)
ATTN: CHRISTIAN TUCHSCHERER PHONE NO : 49 608 1959278 PHILLIP REIS-STRASSE 8/13 SE DECISION MADE: 07-JUL-05 WEHRHEIM, GERMANY D-61273 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PALAMED G HERAEUS KULZER GMBH 510(k) NO: K050855(TRADITIONAL)
ATTN: CHRISTIAN TUCHSCHERER PHONE NO : 496 081 959287 PHILLIP REIS-STRASSE 8/13 SE DECISION MADE: 07-JUL-05 WEHRHEIM, GERMANY D-61273 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIDEKICK BLOOD GLUCOSE TEST SYSTEM HOME DIAGNOSTICS, INC. 510(k) NO: K051147(SPECIAL)
ATTN: KAREN DEVINCENT PHONE NO : 954-677-9201 2400 N.W. 55TH CT. SE DECISION MADE: 12-JUL-05 FORT LAUDERDALE, FL 33309 510(k) STATEMENT DEVICE: TRIATHLON KNEE SYSTEM HOWMEDICA OSTEONICS CORP 510(k) NO: K051146(TRADITIONAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-831-5718 325 CORPORATE DR. SE DECISION MADE: 13-JUL-05 MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOLOX DELTA CERAMIC FEMORAL HEADS HOWMEDICA OSTEONICS CORP 510(k) NO: K051588(SPECIAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-831-5718 325 CORPORATE DR. SE DECISION MADE: 12-JUL-05 MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: T2 RECON NAIL SYSTEM HOWMEDICA OSTEONICS CORP 510(k) NO: K051624(SPECIAL)
ATTN: VIVIAN KELLY PHONE NO : 201-831-5581 325 CORPORATE DR. SE DECISION MADE: 07-JUL-05 MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO V-40/C-TAPER ADAPTER SLEEVE HOWMEDICA OSTEONICS CORP 510(k) NO: K051737(SPECIAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-831-5718 325 CORPORATE DR. SE DECISION MADE: 19-JUL-05 MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SECUR-FIT MAX AND PLUS MAX HIP STEMS HOWMEDICA OSTEONICS CORP 510(k) NO: K051738(SPECIAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-831-5718 325 CORPORATE DR. SE DECISION MADE: 19-JUL-05 MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: T2 ANKLE ARTHRODESIS NAIL HOWMEDICA OSTEONICS CORP. 510(k) NO: K051590(TRADITIONAL)
ATTN: VIVIAN KELLY PHONE NO : 201-831-5581 325 CORPORATE DRIVE SE DECISION MADE: 29-JUL-05 MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HES ULTRASONIC THERAPY APPLIANCE, MODELS HS-3008 (1MHZ), HS3026 HWANG SUN ENTERPRISE CO., LTD. 510(k) NO: K050410(TRADITIONAL)
ATTN: SING-HONG YEUNG PHONE NO : 631-924-2751 11 HEATHER COURT SE DECISION MADE: 14-JUL-05 MIDDLE ISLAND, NY 11953 510(k) STATEMENT DEVICE: EXTREME H2O 54% (HIOXIFILCON D) SOFT CONTACT LENS (SPHERICAL AND HYDROGEL VISION CORPORATION 510(k) NO: K051430(TRADITIONAL)
ATTN: DONNA HOVANEC PHONE NO : 941-739-1382 7575 COMMERCE COURT SE DECISION MADE: 18-JUL-05 SARASOTA, FL 34243 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HUMERAL HEAD PLATE WITH ANGULAR STABILITY I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTE510(k) NO: K051412(TRADITIONAL)
ATTN: AL LIPPINCOTT PHONE NO : 952-492-5858 3150 E. 200TH ST. SE DECISION MADE: 11-JUL-05 PRIOR LAKE, MN 55372 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 1,25-DIHYDROXY VITAMIN D EIA IMMUNODIAGNOSTIC SYSTEMS LTD. 510(k) NO: K051110(ABBREVIATED)
ATTN: PAUL PUNTIN PHONE NO : +44 191 5190660 10 DIDCOT WAY, SE DECISION MADE: 06-JUL-05 BOLDEN BUSINESS PARK 510(k) STATEMENT BOLDON, TYNE & WEAR, UNITED KINGDOM NE35 9PD DEVICE: IMPEDIMED - BODY COMPOSITION ANALYSIS IMPEDIMED PTY LTD. 510(k) NO: K050395(TRADITIONAL)
ATTN: NEVELLI BERTWISTLE PHONE NO : 617 342 31777 BUILDING 4B/2404 LOGAN ROAD SE DECISION MADE: 13-JUL-05 EIGHT MILE PLAINS 510(k) SUMMARY AVAILABLE FROM FDA BRISBANE, QUEENSLAND, AUSTRALIA 4113 DEVICE: RN SYNOCTA TEMPORARY MESO ABUTMENT INSTITUT STRAUMANN SA 510(k) NO: K051717(SPECIAL)
ATTN: LINDA JALBERT PHONE NO : 800-448-8168 60 MINUTEMAN ROAD SE DECISION MADE: 07-JUL-05 ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTRALASE FS LASER INTRALASE CORP. 510(k) NO: K041893(TRADITIONAL)
ATTN: CHARLINE GAUTHIER PHONE NO : 949-859-5230 9701 JERONIMO ROAD SE DECISION MADE: 29-JUL-05 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DYNAGRAFT II DENTAL ISOTIS ORTHOBIOLOGICS, INC 510(k) NO: K043573(TRADITIONAL)
ATTN: PAUL DONER PHONE NO : 949-855-7168 2 GOODYEAR, SUITE B SE DECISION MADE: 29-JUL-05 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONNEXUS ISOTIS ORTHOBIOLOGICS, INC 510(k) NO: K050690(TRADITIONAL)
ATTN: PAUL DONER PHONE NO : 949-855-7168 2 GOODYEAR, SUITE B SE DECISION MADE: 07-JUL-05 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JETLITE 5000 J. MORITA USA, INC. 510(k) NO: K051780(TRADITIONAL)
ATTN: HOWARD ROWE PHONE NO : 949-465-1034 9 MASON SE DECISION MADE: 28-JUL-05 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPRESSOR NEBULIZER SYSTEM, MODEL KN-9321 K-JUMP HEALTH CO., LTD. 510(k) NO: K051365(ABBREVIATED)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001 55 NORHTERN BLVD. SE DECISION MADE: 22-JUL-05 GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALEUTIAN SPACER SYSTEM K2M, LLC 510(k) NO: K051454(TRADITIONAL)
ATTN: RICH WOODS PHONE NO : 703-777-3155 751 MILLER DR.,S.E., SUITE F1 SE DECISION MADE: 27-JUL-05 LEESBURG, VA 20175 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: L.E. DEMETRON II KERR CORPORATION (DANBURY) 510(k) NO: K051545(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484 1717 WEST COLLINS AVE. SE DECISION MADE: 18-JUL-05 ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIRECT DIGITIZER REGIUS MODEL 370 KONICA MINOLTA MEDICAL & GRAPHIC, 510(k) NO: K051418(SPECIAL)
ATTN: SHINICHI MAMANAKA PHONE NO : 815 963 70190 319 AKENO, OBATA-CHO SE DECISION MADE: 01-JUL-05 WATARAI-GUN 510(k) STATEMENT MIE-KEN, JAPAN 519-05 DEVICE: REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE KONICA MINOLTA MEDICAL & GRAPHIC, 510(k) NO: K051523(TRADITIONAL)
ATTN: SHINICHI YAMANAKA PHONE NO : 815 963 70190 319 AKENO, OBATA-CHO SE DECISION MADE: 20-JUL-05 WATARAI-GUN, MIE-KEN, JAPAN 519-05510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AVANTICARE, MODEL SA4022 LERADO CHINA LIMITED 510(k) NO: K051538(TRADITIONAL)
ATTN: JEFF CHANG PHONE NO : 886 422 465396 CHONGDE RD., BEITUN DISTRICT SE DECISION MADE: 21-JUL-05 TAICHUNG, CHINA (TAIWAN) 40653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TESLAOXYSAT, MODEL EFOXYSATE MAMMENDORFER INSTITUTE FOR PHYSICS510(k) NO: K050018(TRADITIONAL)
ATTN: ROBERT N CLARK PHONE NO : 303-234-9412 13605 WEST 7TH AVE. SE DECISION MADE: 01-JUL-05 GOLDEN, CO 80401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MARIAN INFANT FEEDING TUBE (GUARDIANPICC PERCUTANEOUS CENTRAL VE MARIAN MEDICAL, INC. 510(k) NO: K050542(TRADITIONAL)
ATTN: SANDRA WINKLER PHONE NO : 502-552-6189 319 WESTPORT DR. SE DECISION MADE: 26-JUL-05 LOUISVILLE, KY 40207 510(k) STATEMENT DEVICE: MODIFICATION TO LNCS OXIMETRY SENSORS MASIMO CORPORATION 510(k) NO: K051212(SPECIAL)
ATTN: JAMES J CRONIN PHONE NO : 949-297-7000 40 PARKER SE DECISION MADE: 12-JUL-05 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LNOP BLUE OXIMETRY SENSOR MASIMO CORPORATION 510(k) NO: K051439(TRADITIONAL)
ATTN: JAMES J CRONIN PHONE NO : 949-297-7000 40 PARKER SE DECISION MADE: 15-JUL-05 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITAL SIGNS MONITOR MEDIANA CO., LTD. 510(k) NO: K051375(TRADITIONAL)
ATTN: CHARLIE MACK PHONE NO : 931-937-8093 340 SHADY GROVE ROAD SE DECISION MADE: 28-JUL-05 FLINTVILLE, TN 37335 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDICINELODGE ZIPKNOT MEDICINELODGE, INC. 510(k) NO: K051488(TRADITIONAL)
ATTN: M. MRY SINNOTT PHONE NO : 435-753-7675 180 SOUTH 600 WEST SE DECISION MADE: 27-JUL-05 LOGAN, UT 84321 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECHOSYSTEM MEDSTRAT, INC. 510(k) NO: K051745(ABBREVIATED)
ATTN: ROBERT J BISHOP PHONE NO : 630-960-8700 1901 BUTTERFIELD RD. SE DECISION MADE: 14-JUL-05 SUITE 600 510(k) SUMMARY AVAILABLE FROM FDA DOWNERS GROVE, IL 60515 THIRD PARTY REVIEW DEVICE: MODEL 3873 1* 8 AND MODEL 3874 1* 8 COMPACT TEST STIMULATION LEA MEDTRONIC INC.,NEUROLOGICAL DIVISI510(k) NO: K051773(SPECIAL)
ATTN: PAULA CORDERO PHONE NO : 763-505-0238 710 MEDTRONIC PKWY. SE DECISION MADE: 28-JUL-05 MINNEAPOLIS, MN 55432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDTRONIC ORTHOPAEDIC TRAUMA APPLICATION MEDTRONIC NAVIGATION, INC. 510(k) NO: K050651(TRADITIONAL)
ATTN: TINA DREILING PHONE NO : 720-890-3217 826 COAL CREEK CIRCLE SE DECISION MADE: 27-JUL-05 LOUSVILLE, CO 80027 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K051674(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 21-JUL-05 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MS 9/5 HEMATOLOGY ANALYZER MELET SCHLOESING LABORATORIES USA 510(k) NO: K050436(ABBREVIATED)
ATTN: JACKIE COLEMAN PHONE NO : 858-268-8165 7703 CONVOY CT SE DECISION MADE: 27-JUL-05 SAN DIEGO, CA 92111 510(k) STATEMENT DEVICE: MERETE TWISTCUT SNAP-OFF BONE SCREW MERETE MEDICAL GMBH 510(k) NO: K051323(TRADITIONAL)
ATTN: EMMANUEL ANAPLIOTIS PHONE NO : 212-496-2700 269 WEST SEVENTY-FIRST STREET SE DECISION MADE: 07-JUL-05 NEW YORK, NY 10023 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEVIS LIVERANALYSER/LIVERVIEWER SOFTWARE MEVIS TECHNOLOGY GMBH & CO. KG 510(k) NO: K051528(TRADITIONAL)
ATTN: CARL ALLETTO PHONE NO : 940-300-8601 1600 MANCHESTER WAY SE DECISION MADE: 20-JUL-05 CORINTH, TX 76210 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICK HDR INTERSTITIAL IMPLANT ACCESSORIES MICK RADIO-NUCLEAR INSTRUMENTS, IN510(k) NO: K051423(TRADITIONAL)
ATTN: FELIX MIOK PHONE NO : 914-667-3999 521 HOMESTEAD AVE. SE DECISION MADE: 01-JUL-05 MOUNT VERNON, NY 10550 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MILTEX RIGID STERILIZATION CONTAINER SYSTEM MILTEX, INC. 510(k) NO: K050570(TRADITIONAL)
ATTN: LEE ZAGAR PHONE NO : 717-840-3416 589 DAVIES DRIVE SE DECISION MADE: 25-JUL-05 YORK, PA 17402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPIROTEL MIR MEDICAL INTL. RESEARCH SRL 510(k) NO: K043528(TRADITIONAL)
ATTN: SIMON FOWLER PHONE NO : 39 062 2754777 VIA DEL MAGGIOLINO 125 SE DECISION MADE: 19-JUL-05 ROMA, ITALY 00155 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BARRIER SURGICAL DRAPES MOLNLYCKE HEALTH CARE, INC. 510(k) NO: K051625(SPECIAL)
ATTN: JOHN CLAY PHONE NO : 267-685-2078 826 NEWTOWN-YARDLEY RD. SE DECISION MADE: 14-JUL-05 NEWTOWN, PA 18940 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POCKET TRANSCRANIAL AND VASCULAR DOPPLER SPECTRUM ANALYZER, MODE MULTIGON INDUSTRIES, INC. 510(k) NO: K051739(TRADITIONAL)
ATTN: WILLIAM STERN PHONE NO : 914-376-5200 ONE ODELL PLAZA SE DECISION MADE: 28-JUL-05 YONKERS, NY 10701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AFT MUSCULOSKELETAL TRANSPLANT FOUNDAT510(k) NO: K042125(TRADITIONAL)
ATTN: KAREN HARDWICK PHONE NO : 732-661-2354 125 MAY STREET SE DECISION MADE: 28-JUL-05 EDISON, NJ 08837 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3TEST GLUCOSE MONITORING SYSTEM NEUERO ENGINEERING INC. 510(k) NO: K050224(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829 NO 58, FU-CHIUN STREET SE DECISION MADE: 13-JUL-05 HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CERETOM, MODEL NL3000 NEUROLOGICA CORPORATION 510(k) NO: K051765(TRADITIONAL)
ATTN: BRAHIM HADRI PHONE NO : 978-564-8500 14 ELECTRONICS AVENUE SE DECISION MADE: 14-JUL-05 DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: NEURORECOVERY, INC. (NRI) COMPREHENSIVE INTRACRANIAL PRESSURE EV NEURORECOVERY, INC. 510(k) NO: K051599(TRADITIONAL)
ATTN: ROSINA ROBINSON PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 19-JUL-05 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOBELREPLACE ADAPTER, MODEL 32412 NOBEL BIOCARE USA, INC. 510(k) NO: K050444(TRADITIONAL)
ATTN: ELIZABETH J MASON PHONE NO : 714-282-4800 22715 SAVI RANCH PKWY. SE DECISION MADE: 07-JUL-05 YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SILVERSEAL ORTHOTIC COMPONENT WITH X-STATIC NOBLE FIBER TECHNOLOGIES, INC. 510(k) NO: K051256(TRADITIONAL)
ATTN: WILLIAM F MCNALLY PHONE NO : 877-978-2842 421 SOUTH STATE ST. SE DECISION MADE: 21-JUL-05 CLARKS SUMMIT, PA 18411 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NAVIGATOR NOMOS CORP. 510(k) NO: K042875(TRADITIONAL)
ATTN: LEIGH SPOTTEN PHONE NO : 818-734-8600 200 WEST KENSINGER DR. SE DECISION MADE: 01-JUL-05 CRANBERRY TOWNSHIP, PA 16066 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NORWOOD ABBEY CENTURION SES EPIKERATOME NORWOOD ABBEY , LTD. 510(k) NO: K051486(SPECIAL)
ATTN: PAUL CLARK PHONE NO : 613 978 27308 63 WELLS RD. SE DECISION MADE: 06-JUL-05 CHELSEA HGTS., VICTORIA, AUSTRALIA510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HUBER CLEAR SAFETY INFUSION SET NOW MEDICAL DISTRIBUTION, INC. 510(k) NO: K051009(TRADITIONAL)
ATTN: CHRISTINE EMANNUEL PHONE NO : 805-963-4312 1205 DE LA VINA STREET SE DECISION MADE: 12-JUL-05 SANTA BARBARA, CA 93101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIB PTA BALLOON CATHETER NUMED, INC. 510(k) NO: K050857(TRADITIONAL) ATTN: JODI GIJANTO PHONE NO : 315-328-4491 2880 MAIN ST. SE DECISION MADE: 28-JUL-05 HOPKINTON, NY 12965 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MINI GHOST PTA CATHETER, MODEL 507 NUMED, INC. 510(k) NO: K051343(SPECIAL)
ATTN: NICHELLE LAFLESH PHONE NO : 315-328-4491 2880 MAIN ST. SE DECISION MADE: 28-JUL-05 HOPKINTON, NY 12965 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: NUVASIVE NEUROVISION JJB SYSTEM NUVASIVE, INC. 510(k) NO: K051384(SPECIAL)
ATTN: LAETITIA COUSIN PHONE NO : 858-909-1868 4545 TOWNE CENTRE CT. SE DECISION MADE: 11-JUL-05 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GF-UE160-AL5 ULTRASOUND ENDOSCOPE OLYMPUS AMERICA, INC. 510(k) NO: K051541(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688 TWO CORPORATE CENTER DR. SE DECISION MADE: 01-JUL-05 MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SINGLE USE BALLOON DILATOR MAXPASSTM OLYMPUS WINTER & IBE GMBH 510(k) NO: K050502(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688 TWO CORPORATE CENTER DR. SE DECISION MADE: 08-JUL-05 MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EYE-CEPT REWETTING DROPS OPTICS LABORATORY, INC. 510(k) NO: K041008(TRADITIONAL)
ATTN: J.R. CHEN PHONE NO : 318-635-1594 5408 INTERSTATE DRIVE SE DECISION MADE: 01-JUL-05 SHREVEPORT, LA 71109 510(k) STATEMENT DEVICE: LUMIPHASE-R OPUSMED INC. 510(k) NO: K051255(TRADITIONAL)
ATTN: IAN GORDON PHONE NO : 727-797-4727 2454 MCMULLEN BOOTH ROAD SE DECISION MADE: 01-JUL-05 SUITE 427 510(k) SUMMARY AVAILABLE FROM FDA CLEARWATER, FL 33759 DEVICE: BIORESORB MACRO PORE ORALTRONICS DENTAL IMPLANT TECHNOL510(k) NO: K050260(TRADITIONAL)
ATTN: CHAD BARTEE PHONE NO : 806-796-1923 3234 64TH ST. SE DECISION MADE: 15-JUL-05 LUBBOCK, TX 79413 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PIVOT BIPOLAR FEMORAL HEAD ORTHO DEVELOPMENT CORP. 510(k) NO: K050966(TRADITIONAL)
ATTN: WILLIAM J GRIFFIN PHONE NO : 801-553-9991 12187 SOUTH BUSINESS PARK DR. SE DECISION MADE: 07-JUL-05 DRAPER, UT 84020 510(k) STATEMENT DEVICE: EQUA-PULL SAFETY RELEASE MODULE ORTHO TECHNOLOGY 510(k) NO: K051751(TRADITIONAL)
ATTN: STEVE KLAMIC PHONE NO : 813-991-5896 17401 COMMERCE PARK BOULEVARD SE DECISION MADE: 22-JUL-05 TAMPA, FL 33647 510(k) STATEMENT DEVICE: GENEROS SB SMALL BONE DISTRACTION IMPLANT ORTHONETX, INC. 510(k) NO: K051162(TRADITIONAL)
ATTN: TERRY KNAPP PHONE NO : 303-494-1681 1000 S. MACCASLIN BLVD. SE DECISION MADE: 19-JUL-05 SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA SUPERIOR, CO 80027 DEVICE: OSCAR, MODEL OE3000DB ORTHOSONICS, LTD. 510(k) NO: K051053(TRADITIONAL)
ATTN: T. WHIT ATHEY PHONE NO : 301-570-0013 2305 GOLD MINE RD. SE DECISION MADE: 21-JUL-05 BROOKEVILLE, MD 20833 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SCAN300FP / RETROPAN (VDC) OY AJAT, LTD. 510(k) NO: K051664(TRADITIONAL)
ATTN: CLAUDE D BERTHOIN PHONE NO : 386-672-0450 110 E GRANADA BLVD. SUITE 207 SE DECISION MADE: 20-JUL-05 ORMOND BEACH, FL 32176 510(k) STATEMENT DEVICE: POWDERED LATEX PATIENT EXAMINATION GLOVES P.T. ANLIS ABADI INTERNASIONAL 510(k) NO: K051465(TRADITIONAL)
ATTN: HUAN-CHUNG LI PHONE NO : 978-436-9980 17A STERLING ROAD SE DECISION MADE: 12-JUL-05 NORTH BILLERICA, MA 01862 510(k) STATEMENT DEVICE: THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 IN PHILIPS MEDIZINSYSTEME BOEBLINGEN 510(k) NO: K051106(SPECIAL)
ATTN: HAUKE SCHIK PHONE NO : +49 703 14632031 HEWLETT-PACKARD STR.2 SE DECISION MADE: 01-JUL-05 BOEBLINGEN, GERMANY D 71034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES WITH PEPPERMINT SCENTED ( PLATINUM GLOVE INDUSTRIES SDN.BHD.510(k) NO: K051372(TRADITIONAL)
ATTN: SO SOON CHEAW PHONE NO : 603 214 44215 4015A, FL 4,PRESIDENT HSE, SE DECISION MADE: 07-JUL-05 JLN SULTAN ISMAIL 510(k) STATEMENT KUALA LUMPUR, MALAYSIA 50250 DEVICE: POWDERFREE POLYCHLOROPRENE STERILE EXAMINATION GLOVES PT. MEDISAFE TECHNOLOGIES 510(k) NO: K050968(TRADITIONAL)
ATTN: ANIL TANEJA PHONE NO : 620 617 941493 JL.BATANG KUIS GG.TAMBAK REJO SE DECISION MADE: 12-JUL-05 DESA BUNTU BEDIMBAR TJ. MORAWA 510(k) STATEMENT MEDAN, NORTH SUMATERA, INDONESIA 20362 DEVICE: LTV 1000 VENTILATOR PULMONETIC SYSTEMS, INC. 510(k) NO: K051767(SPECIAL)
ATTN: ROBERT C SAMEC PHONE NO : 763-398-8305 17400 MEDINA ROAD SE DECISION MADE: 29-JUL-05 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA MINNEAPOLIS, MN 55447 DEVICE: QUANTUM VERTEBRAL BODY REPLACEMENT QUANTUM ORTHOPEDICS, INC. 510(k) NO: K050449(TRADITIONAL)
ATTN: JASON BLAIN PHONE NO : 760-607-0121 2744 LOKER AVE. W. SUITE 100 SE DECISION MADE: 07-JUL-05 CARLSBAD, CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUEST DIAGNOSTICS HAIRCHECK-DT (OPIATES) QUEST DIAGNOSTICS, INC. 510(k) NO: K042725(TRADITIONAL)
ATTN: JAMES A BOURLAND PHONE NO : 702-733-3769 4230 BURNHAM AVE. SE DECISION MADE: 06-JUL-05 LAS VEGAS, NV 89119-5410 510(k) STATEMENT DEVICE: QUEST DIAGNOSTICS HAIRCHECK-DT (PCP QUEST DIAGNOSTICS, INC. 510(k) NO: K042726(TRADITIONAL)
ATTN: JAMES A BOURLAND PHONE NO : 702-733-3769 4230 BURNHAM AVE. SE DECISION MADE: 28-JUL-05 LAS VEGAS, NV 89119-5410 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: R&D CBC-4K PLUS RETICS HEMATOLOGY CONTROL R & D SYSTEMS, INC. 510(k) NO: K051339(SPECIAL)
ATTN: RALPH E HOGANCAMP PHONE NO : 612-656-4413 614 MCKINLEY PL., N.E. SE DECISION MADE: 12-JUL-05 MINNEAPOLIS, MN 55413 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: R2 BREAST IMAGING WORKSTATION R2 TECHNOLOGY, INC. 510(k) NO: K051743(TRADITIONAL)
ATTN: DENISE F GOTTFRIED PHONE NO : 408-481-5646 1195 WEST FREMONT AVE. SE DECISION MADE: 25-JUL-05 SUNNYVALE, CA 94087 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: RADIANCE ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT RADIANCY, LTD. 510(k) NO: K051268(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794 555 13TH ST. NW SE DECISION MADE: 06-JUL-05 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROI FUSION RODS & PLATES REILEY ORTHOPAEDICS, INC. 510(k) NO: K051309(TRADITIONAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199 1001 OAKWOOD BLVD. SE DECISION MADE: 11-JUL-05 ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FRAXEL SR LASER SYSTEM RELIANT TECHNOLOGIES, INC. 510(k) NO: K050841(TRADITIONAL)
ATTN: HEATHER TANNER PHONE NO : 650-473-0200 260 SHERIDAN AVE. SE DECISION MADE: 05-JUL-05 SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA PALO ALTO, CA 94306 DEVICE: RES TRAXX DATA CENTER RESMED LTD. 510(k) NO: K051314(TRADITIONAL)
ATTN: DAVID D'CRUZ PHONE NO : 858-746-2238 14040 DANIELSON ST. SE DECISION MADE: 15-JUL-05 POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ESPRIT VENTILATOR NEONATAL OPTION, MODEL V1000 RESPIRONICS CALIFORNIA, INC. 510(k) NO: K051262(TRADITIONAL)
ATTN: MARY FUNK PHONE NO : 760-918-7300 2271 COSMOS CT. SE DECISION MADE: 08-JUL-05 CARLSBAD, CA 92009 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROCHE ELECSYS TROPONIN T STAT (SHORT TURNAROUND TIME) ROCHE DIAGNOSTICS 510(k) NO: K051752(SPECIAL)
ATTN: THERESA M AMBROSE PHONE NO : 317-521-3544 9115 HAGUE ROAD SE DECISION MADE: 11-JUL-05 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECSYS CA 19-9 IMMUNOASSAY, ELECSYS CA 19-9 CALSET ROCHE DIAGNOSTICS CORP. 510(k) NO: K050231(TRADITIONAL)
ATTN: KAY A TAYLOR PHONE NO : 317-521-3544 9115 HAGUE RD. SE DECISION MADE: 06-JUL-05 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECSYS CA 19-9 CALCHECK ROCHE DIAGNOSTICS CORP. 510(k) NO: K051185(TRADITIONAL)
ATTN: CORINA HARPER PHONE NO : 317-521-3831 9115 HAGUE RD. SE DECISION MADE: 06-JUL-05 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECSYS PRECICONTROL ANEMIA ROCHE DIAGNOSTICS CORP. 510(k) NO: K051517(TRADITIONAL)
ATTN: CORNIA HARPER PHONE NO : 317-521-3831 9115 HAGUE RD. SE DECISION MADE: 05-JUL-05 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECSYS PRECICONTROL UNIVERSAL ROCHE DIAGNOSTICS CORP. 510(k) NO: K051687(TRADITIONAL)
ATTN: CORINA HARPER PHONE NO : 317-521-3831 9115 HAGUE RD. SE DECISION MADE: 25-JUL-05 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROGESTERONE STANDARD CALIBRATOR, ONE (1) ML OF PROGESTERONE IN SALIMETRICS LLC. 510(k) NO: K051012(TRADITIONAL)
ATTN: VIRGINIA MCKAY MCKAY PHONE NO : 814-234-7748 101 INNOVATION BLVD. SUITE 302 SE DECISION MADE: 19-JUL-05 STATE COLLEGE, PA 16803-6605 510(k) STATEMENT DEVICE: SANARUS CASSI II ROTATIONAL CORE BIOPSY SYSTEM, MODEL CS2000 SANARUS MEDICAL, INC. 510(k) NO: K051581(TRADITIONAL)
ATTN: TRENA DEPEL PHONE NO : 925-460-6080 4696 WILLOW RD. SE DECISION MADE: 27-JUL-05 PLEASANTON, CA 94588 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAFETY NEEDLE SARSTEDT, INC. 510(k) NO: K051019(TRADITIONAL)
ATTN: PETER RUMSWINKEL PHONE NO : 828-465-4000 1025 ST. JAMES CHURCH RD. SE DECISION MADE: 25-JUL-05 NEWTON, NC 28658 510(k) STATEMENT DEVICE: WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILUMINOMETRIC ASSAY (ICMA), SCANTIBODIES LABORATORY, INC. 510(k) NO: K051141(TRADITIONAL)
ATTN: MICHAEL NORDSTROM PHONE NO : 619-258-9300 9336 ABRAHAM WAY SE DECISION MADE: 26-JUL-05 SANTEE, CA 92071 510(k) STATEMENT DEVICE: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT SCANTIBODIES LABORATORY, INC. 510(k) NO: K051150(TRADITIONAL)
ATTN: MICHAEL NORDSTROM PHONE NO : 619-258-9300 9336 ABRAHAM WAY SE DECISION MADE: 26-JUL-05 SANTEE, CA 92071 510(k) STATEMENT DEVICE: MALIBU SPINAL SYSTEM SEASPINE, INC. 510(k) NO: K051663(TRADITIONAL)
ATTN: DIANA SMITH PHONE NO : 760-727-8399 2303 LA MIRADA DR. SE DECISION MADE: 12-JUL-05 VISTA, CA 92081-7862 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MALIBU SPINAL SYSTEM SEASPINE, INC. 510(k) NO: K051942(TRADITIONAL)
ATTN: DIANA SMITH PHONE NO : 760-727-8399 2302 LA MIRADA DRIVE SE DECISION MADE: 27-JUL-05 VISTA, CA 92081-7862 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SENTINEL PLASMAPROTEINS CAL 3X SENTINEL CH. SRL 510(k) NO: K051457(ABBREVIATED)
ATTN: DAVIDE SPADA PHONE NO : 39 02 3455141 5 VIA PRINCIPE EUGENIO SE DECISION MADE: 25-JUL-05 MILANO, ITALY 20155 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TISSU-TRANS SHIPPERT MEDICAL TECHNOLOGIES CORP510(k) NO: K050797(TRADITIONAL)
ATTN: SARAH LAKE PHONE NO : 303-754-0044 6248 SOUTH TROY CIRCLE SE DECISION MADE: 13-JUL-05 UNIT A 510(k) STATEMENT CENTENNIAL, CO 80111 DEVICE: NITRILE EXAMINATION GLOVES, POWDER FREE SHUN THAI RUBBER GLOVES INDUSTRY C510(k) NO: K051333(TRADITIONAL)
ATTN: ANAN JETSADAWISUT PHONE NO : 662 274 0550 238/1 RATCHADA-PISEK ROAD SE DECISION MADE: 22-JUL-05 HUAY-KWANG, BANGKOK 10310 510(k) STATEMENT THAILAND, THAILAND DEVICE: STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATIN SIAM SEMPERMED CORP. LTD. 510(k) NO: K051329(ABBREVIATED)
ATTN: WILLIAM E HARRIS PHONE NO : 727-787-7250 13900 49TH STREET NORTH SE DECISION MADE: 19-JUL-05 CLEARWATER, FL 33762 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AXIOM SIRESKOP SD SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K051602(TRADITIONAL)
ATTN: GARY JOHNSON PHONE NO : 610-448-1778 51 VALLEY STREAM PARKWAY E-50 SE DECISION MADE: 07-JUL-05 MALVERN, PA 19355-1406 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SEMIAL SPINAL IMPLANT SIGNUS MEDIZINTECHNIK GMBH 510(k) NO: K051659(SPECIAL)
ATTN: TRACY L GRAY PHONE NO : 763-588-9873 4050 OLSON MEMORIAL HWY SE DECISION MADE: 13-JUL-05 SUITE 350 510(k) SUMMARY AVAILABLE FROM FDA MINNEAPOLIS, MN 55422 DEVICE: OSTEOVATION CMF BONE VOID FILLER SKELETAL KINETICS, LLC 510(k) NO: K051784(SPECIAL)
ATTN: DURAN YETKINLER PHONE NO : 408-366-5002 10201 BUBB RD. SE DECISION MADE: 20-JUL-05 CUPERTINO, CA 95014-4167 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMITH & NEPHEW CDS SYSTEM SMITH & NEPHEW, INC. 510(k) NO: K051136(TRADITIONAL)
ATTN: DIANE E MINEAR PHONE NO : 978-749-1441 150 MINUTEMAN RD. SE DECISION MADE: 01-JUL-05 ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROFIX FLEX CRUCIATE RETAINING ARTICULAR INSERT SMITH & NEPHEW, INC. 510(k) NO: K051229(TRADITIONAL)
ATTN: JASON SELLS PHONE NO : 901-399-5520 1450 E. BROOKS RD. SE DECISION MADE: 20-JUL-05 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PLC SCREW SMITH & NEPHEW, INC. 510(k) NO: K051310(TRADITIONAL)
ATTN: BILL MCCALLUM PHONE NO : 508-261-3658 150 MINUTEMAN ROAD SE DECISION MADE: 26-JUL-05 ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERI-LOC LOCKING BONE PLATES AND LOCKING BONE SCREWS FOR THE UPP SMITH & NEPHEW, INC. 510(k) NO: K051735(TRADITIONAL)
ATTN: DAVID HENLEY PHONE NO : 901-399-6487 1450 E. BROOKS RD. SE DECISION MADE: 19-JUL-05 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LOCK-IT PLUS REGIONAL ANESTHESIA CATHETER SECUREMENT DEVICE, MOD SMITHS MEDICAL ASD, INC. 510(k) NO: K051524(TRADITIONAL)
ATTN: CYNTHIA ENGELHARDT PHONE NO : 603-352-3812 10 BOWMAN DRIVE SE DECISION MADE: 07-JUL-05 KEENE, NH 03431 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOLCO 4CIS GENERAL PLATE SYSTEM SOLCO BIOMEDICAL CO., LTD. 510(k) NO: K051155(TRADITIONAL)
ATTN: SAEYOUNG AHN PHONE NO : 301-469-7912 7612 BARNUM ROAD SE DECISION MADE: 11-JUL-05 BETHESDA, MD 20817 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOMNOMED MAS RXA SOMNOMED LTD 510(k) NO: K050592(TRADITIONAL)
ATTN: ELAINE DUNCAN PHONE NO : 715-549-6035 PO BOX 560 SE DECISION MADE: 12-JUL-05 STILLWATER, MN 55082 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPEL 1-PLY SURGICAL GOWNS; COMPEL ISOLATION GOWNS STANDARD TEXTILE CO., INC. 510(k) NO: K041653(TRADITIONAL)
ATTN: BRADLEY J BUSHMAN PHONE NO : 513-761-9255 ONE KNOLLCREST DR. SE DECISION MADE: 01-JUL-05 P.O. BOX 371805 510(k) SUMMARY AVAILABLE FROM FDA CINCINNATI, OH 45237-1600 DEVICE: EXCALIBUR IV LIGHT THERAPY SYSTEM, MODEL SGEX4-001 STARGATE INTERNATIONAL, INC. 510(k) NO: K051631(TRADITIONAL)
ATTN: ROBERT H WALKER PHONE NO : 303-840-8206 10235 SOUTH PROGRESS WAY, #7 SE DECISION MADE: 27-JUL-05 PARKER, CO 80134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED COLD BIOPSY FORCEPS STERILMED, INC. 510(k) NO: K042648(TRADITIONAL)
ATTN: BRUCE LESTER PHONE NO : 888-856-4870 11400 73RD AVE. NORTH, #100 SE DECISION MADE: 20-JUL-05 MAPLE GROVE, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED HOT BIOPSY FORCEPS STERILMED, INC. 510(k) NO: K050136(TRADITIONAL)
ATTN: BRUCE R LESTER PHONE NO : 763-488-3400 11400 73RD AVE. NORTH, #100 SE DECISION MADE: 20-JUL-05 MAPLE GROVE, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MIELO-CAN, BEST-LISAS, BEN - BONE BIOPSY. FAST-CUT, COLT, SPRIN STERYLAB S.R.L. 510(k) NO: K051506(TRADITIONAL)
ATTN: PAUL E DRYDEN PHONE NO : 317-335-3780 6329 W. WATERVIEW CT. SE DECISION MADE: 27-JUL-05 MCCORDSVILLE, IN 46055-9501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMPRUV A.I. CREAM WOUND AND SKIN EMULSION STIEFEL LABORATORIES, INC. 510(k) NO: K041342(TRADITIONAL)
ATTN: MARY JANE CARR PHONE NO : 518-239-6901 ROUTE 145 SE DECISION MADE: 19-JUL-05 OAK HILL, NY 12460 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XIA 4.5 SPINAL SYSTEM STRYKER SPINE 510(k) NO: K050461(TRADITIONAL)
ATTN: SIMONA VOIC PHONE NO : 201-760-8145 2 PEARL COURT SE DECISION MADE: 27-JUL-05 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE EDGE DETECTOR, MODEL 1118 SUN NUCLEAR CORP. 510(k) NO: K051921(TRADITIONAL)
ATTN: NOEL M DOWNEY PHONE NO : 321-259-6862 425-A PINEDA COURT SE DECISION MADE: 27-JUL-05 MELBOURNE, FL 32940 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYMBIOS DISPOSABLE INFUSION PUMP KIT SYMBIOS MEDICAL PRODUCTS, LLC 510(k) NO: K051474(SPECIAL)
ATTN: JEFFERY J ALHOLM PHONE NO : 317-331-8235 6131 WEST 80TH STREET SE DECISION MADE: 01-JUL-05 INDIANAPOLIS, IN 46278-1344 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES (USA) LOW-PROFILE WRIST FIXATOR SYNTHES (USA) 510(k) NO: K051049(TRADITIONAL)
ATTN: KATHY ANDERSON PHONE NO : 610-719-5860 1302 WRIGHTS LANE EAST SE DECISION MADE: 13-JUL-05 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES (USA) DISTRACTION OSTEOGENESIS SYSTEM SYNTHES (USA) 510(k) NO: K051600(TRADITIONAL)
ATTN: KATHY ANDERSON PHONE NO : 610-719-5860 1302 WRIGHTS LANE EAST SE DECISION MADE: 27-JUL-05 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES (USA) BONE MARROW ASPIRATION SYRINGE SYNTHES (USA) 510(k) NO: K051720(TRADITIONAL)
ATTN: KATHY ANDERSON PHONE NO : 610-719-5860 1302 WRIGHTS LANE EAST SE DECISION MADE: 25-JUL-05 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEVER TD-1107 EAR/SKIN/SURFACE IR THERMOMETER, CLEVER TD-1110 E TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K050463(TRADITIONAL)
ATTN: SHU-MEI WU PHONE NO : 886 266 358080 4F, 88, SEC.1, KWANG FU ROAD SE DECISION MADE: 27-JUL-05 SAN CHUNG, TAIPEI, CHINA (TAIWAN) 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TOX A/B QUICK CHEK TECHLAB, INC. 510(k) NO: K050891(TRADITIONAL)
ATTN: DAVID M LYERLY PHONE NO : 540-953-1664 2001 KRAFT DR. SE DECISION MADE: 25-JUL-05 BLACKSBURG, VA 24060-6358 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR TECO DIAGNOSTICS 510(k) NO: K050823(TRADITIONAL)
ATTN: JIAN VAECHES PHONE NO : 714-693-7788 1268 NORTH LAKEVIEW AVE. SE DECISION MADE: 26-JUL-05 ANAHEIM, CA 92807 510(k) STATEMENT DEVICE: BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT THE BINDING SITE 510(k) NO: K042579(TRADITIONAL)
ATTN: JAY H GELLER PHONE NO : 310-449-1399 WEST TOWER, SUITE 4000 SE DECISION MADE: 28-JUL-05 2425 WEST OLYMPIC BLVD. 510(k) SUMMARY AVAILABLE FROM FDA SANTA MONICA, CA 90404 DEVICE: THERALASE TLC-1000 THERAPEUTIC MEDICAL LASER SYSTEM THERALASE INC. 510(k) NO: K050342(TRADITIONAL)
ATTN: ROGER WHITE PHONE NO : 905 947 8455 600 ALDEN ROAD SE DECISION MADE: 11-JUL-05 SUITE 101 510(k) SUMMARY AVAILABLE FROM FDA MARKHAM, ONTARIO, CANADA L3R 0E7 DEVICE: THERMAGE THERMACOOL COUPLING FLUID THERMAGE, INC. 510(k) NO: K051710(TRADITIONAL)
ATTN: PAMELA M BUCKMAN PHONE NO : 510-259-7116 4058 POINT EDEN WAY SE DECISION MADE: 19-JUL-05 HAYWARD, CA 94545-3721 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPI EASY TEMPORARY CAP THOMMEN MEDICAL, AG 510(k) NO: K051527(TRADITIONAL)
ATTN: FLOYD G LARSON PHONE NO : 858-792-1235 11234 EL CAMINO REAL, STE. 200 SE DECISION MADE: 28-JUL-05 SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TORNIER ELBOW PROSTHESIS TORNIER S.A. 510(k) NO: K050848(TRADITIONAL)
ATTN: MIREILLE LEMERY PHONE NO : 304 766 13898 161 RUE LAVOISIER SE DECISION MADE: 14-JUL-05 MONTBONNOT, SAINT-ISMIER, FRANCE 3510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QD KNEE/FOOT COIL, MODEL MJQJ-147A TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K051763(TRADITIONAL)
ATTN: MICHAELA MAHL PHONE NO : 714-730-5000 2441 MICHELLE DR. SE DECISION MADE: 14-JUL-05 P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA TUSTIN, CA 92781-2068 THIRD PARTY REVIEW DEVICE: TSX-101A/H AQUILION 64 SP CT SCANNER; TSX-101A/I AQUILION 32 SP TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K051833(TRADITIONAL)
ATTN: PAUL BIGGINGS PHONE NO : 714-730-5000 2441 MICHELLE DR. SE DECISION MADE: 15-JUL-05 P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA TUSTIN, CA 92781-2068 THIRD PARTY REVIEW DEVICE: 19-INCH (48CM) COLOR LCD MONITOR CDL1904A TOTOKU ELECTRIC CO., LTD. 510(k) NO: K051403(TRADITIONAL)
ATTN: MIKIO HASEGAWA PHONE NO : 812 683 45469 300 OYA, UEDA SE DECISION MADE: 14-JUL-05 NAGANO, JAPAN 386-0192 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWERMAX 25, MODEL PM25; POWERMAX 30, MODEL PM30 TPC ADVANCED TECHNOLOGY, INC. 510(k) NO: K051547(SPECIAL)
ATTN: SCOTT BECKLEY PHONE NO : 626-810-4337 17588 E. ROWLAND ST. SE DECISION MADE: 14-JUL-05 CITY OF INDUSTRY, CA 91748 510(k) STATEMENT DEVICE: OMNITECH SYSTEM & EASY LOCK OSTEOSYSTEM WITH XTREMITIES PLATES TRIMED, INC. 510(k) NO: K050681(TRADITIONAL)
ATTN: KELLI ANDERSON PHONE NO : 661-312-7150 25864 TOURNAMENT RD. SUITE E SE DECISION MADE: 27-JUL-05 VALENCIA, CA 91355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CALC-I-OSS ULTRADENT PRODUCTS, INC. 510(k) NO: K042583(TRADITIONAL)
ATTN: TAMMY LAVERY PHONE NO : 801-553-4200 505 WEST 10200 SOUTH SE DECISION MADE: 19-JUL-05 SOUTH JORDAN, UT 84095 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 55 SV, MULTIFOCAL AND TORIC (OCUFILCON C) SOFT (HYDROPHILIC) CO UNITED CONTACT LENS, INC. 510(k) NO: K051184(TRADITIONAL)
ATTN: GAROLD L EDWARDS PHONE NO : 408-221-3860 2091 UPPER SCENIC DRIVE SE DECISION MADE: 01-JUL-05 FELTON, CA 95018 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRANSEAR BONE CONDUCTION HEARING AID UNITED HEARING SYSTEMS, INC. 510(k) NO: K050653(TRADITIONAL)
ATTN: RALPH CAMPAGNA PHONE NO : 860-564-4130 137 NORWICH RD. SE DECISION MADE: 01-JUL-05 CENTRAL VILLAGE, CT 06332 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: USGI SHAPELOCK ENDOSCOPIC GUIDE USGI MEDICAL 510(k) NO: K051919(SPECIAL)
ATTN: MARY LOU MOONEY PHONE NO : 949-369-3890 1140 CALLE CORDILLERA SE DECISION MADE: 26-JUL-05 SAN CLEMENTE, CA 92673 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VALLEYLAB G3000 ELECTROSURGICAL INSTRUMENT VALLEYLAB 510(k) NO: K051627(TRADITIONAL)
ATTN: HERBERT VINSON PHONE NO : 303-530-6469 5920 LONGBOW DR. SE DECISION MADE: 22-JUL-05 BOULDER, CO 80301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES VANGUARD MEDICAL CONCEPTS, INC. 510(k) NO: K051180(TRADITIONAL)
ATTN: HEATHER CRAWFORD PHONE NO : 863-683-8680 5307 GREAT OAK DR. SE DECISION MADE: 22-JUL-05 LAKELAND, FL 33815 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITESSE 2.0 VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K051497(TRADITIONAL)
ATTN: VY TRAN PHONE NO : 650-424-6990 3100 HANSEN WAY SE DECISION MADE: 18-JUL-05 PALO ALTO, CA 94304 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VARI-LASE ENDOVENOUS LASER PROCEDURE KIT VASCULAR SOLUTIONS, INC. 510(k) NO: K051287(TRADITIONAL)
ATTN: LINDA BUSKLEIN PHONE NO : 763-656-4217 6464 SYCAMORE COURT NORTH SE DECISION MADE: 29-JUL-05 MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMASK, MODELS 100, 200 AND 300 VITAL SIGNS COLORADO, INC. 510(k) NO: K051559(SPECIAL)
ATTN: TOM DIELMANN PHONE NO : 303-790-4835 11039 EAST LANSING CIR. SE DECISION MADE: 08-JUL-05 ENGLEWOOD, CO 80112 510(k) STATEMENT DEVICE: GRANDIO VOCO GMBH 510(k) NO: K051867(SPECIAL)
ATTN: GERALD W SHIPPS PHONE NO : 541-389-5935 19379 BLUE LAKE LOOP SE DECISION MADE: 27-JUL-05 BEND, OR 97702 510(k) STATEMENT DEVICE: GRANDIO FLOW VOCO GMBH 510(k) NO: K051868(SPECIAL)
ATTN: GERALD W SHIPPS PHONE NO : 541-389-5935 19379 BLUE LAKE LOOP SE DECISION MADE: 27-JUL-05 BEND, OR 97702 510(k) STATEMENT DEVICE: MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT WALLAC OY 510(k) NO: K050960(SPECIAL)
ATTN: GUNNEL LAAKSONEN PHONE NO : 358 226 78111 MUSTIONKATU 6 SE DECISION MADE: 11-JUL-05 TURKU, FINLAND 20750 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIROX WIELAND DENTAL + TECHNIK GMBH & CO510(k) NO: K051249(TRADITIONAL)
ATTN: GERHARD POLZER PHONE NO : +49 072 313705219 SCHWENNINGER STRABE 13 SE DECISION MADE: 22-JUL-05 PFORZHEIM, GERMANY D-75179 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GONGDONG DISPOSABLE VAGINAL SPECULUM ZHEJIANG GONGDONG MEDICAL PLASTIC 510(k) NO: K050887(ABBREVIATED)
ATTN: WEIFENG ZHONG PHONE NO : 86 576 4051888 BEICHENG INDUSTRIAL AREA SE DECISION MADE: 11-JUL-05 HUANGYAN, CHINA 318020 510(k) STATEMENT DEVICE: ELITE IMPLANT ZHERMACK S.P.A. 510(k) NO: K050417(TRADITIONAL)
ATTN: GERALD W SHIPPS PHONE NO : 541-389-5935 19379 BLUE LAKE LOOP SE DECISION MADE: 19-JUL-05 BEND, OR 97702 510(k) STATEMENT DEVICE: HYDROGUM 5 ZHERMACK S.P.A. 510(k) NO: K051424(TRADITIONAL)
ATTN: GERALD W SHIPPS PHONE NO : 514-389-5935 19379 BLUE LAKE LOOP SE DECISION MADE: 15-JUL-05 BEND, OR 97702 510(k) STATEMENT DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (WHITE, YELLOW) ZIBO SINOCARE PLASTIC PRODUCTS CO.510(k) NO: K051723(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : +86 108 2387441 209 BEI SI HUAN ZHONG ROAD SE DECISION MADE: 15-JUL-05 HAIDIAN DISTRICT, BLDG. 1 510(k) SUMMARY AVAILABLE FROM FDA BEIJING, CHINA 100083 DEVICE: ANATOMICAL SHOULDER KEELED GLENOID ZIMMER GMBH 510(k) NO: K051623(SPECIAL)
ATTN: BRANDON HIPSHER PHONE NO : 574-371-8083 P.O. BOX 708 SE DECISION MADE: 19-JUL-05 WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO:TRABECULAR METAL FEMORAL CONE AUGMENTS, MODELS 0 ZIMMER TRABECULAR 510(k) NO: K051756(SPECIAL)
ATTN: MARCI HALEVI PHONE NO : 201-818-1800 80 COMMERCE DR. SE DECISION MADE: 27-JUL-05 ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERIARTICULAR LOCKING PLATES AND SCREWS, MODEL 2358 SERIES ZIMMER, INC. 510(k) NO: K051098(TRADITIONAL)
ATTN: LAURA D WILLIAMS PHONE NO : 574-372-4523 P.O. BOX 708 SE DECISION MADE: 07-JUL-05 WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRABECULAR METAL REVISION SHELL LINERS ZIMMER, INC. 510(k) NO: K051516(SPECIAL)
ATTN: TONY KINGSLEY PHONE NO : 574-372-4485 P.O. BOX 708 SE DECISION MADE: 27-JUL-05 WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZUTRON COLONOSCOPE STIFFENING DEVICE ZUTRON MEDICAL 510(k) NO: K051068(TRADITIONAL)
ATTN: JOSEPH M AZARY PHONE NO : 203-944-9320 543 LONG HILL AVENUE SE DECISION MADE: 11-JUL-05 SHELTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 260 TOTAL WITH SUMMARIES 221 TOTAL WITH STATEMENTS 39
Updated August 8, 2005
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