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510(k)s Final Decisions Rendered for October 2000 |
SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE) 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD 01-OCT-2000 THROUGH 31-OCT-2000 DEVICE: DMLC IV-ERGO 3D LINE USA, INC. 510(k) NO: K001163(TRADITIONAL) ATTN: KAREN H RIGAMONTI PHONE NO : 410-580-1730 2807 OLD COURT ROAD SE DECISION MADE: 23-OCT-00 BALTIMORE, MD 21208 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPIROL EPIDURAL CATHETER ABBOTT LABORATORIES 510(k) NO: K000886(TRADITIONAL) ATTN: JILL N SACKETT PHONE NO : 847-937-4085 D-389, BLDG. AP30 SE DECISION MADE: 05-OCT-00 200 ABBOTT PARK ROAD 510(k) STATEMENT ABBOTT PARK, IL 60064-6157 DEVICE: ABX MICROS CRP ABX DIAGNOSTICS, INC. 510(k) NO: K002646(TRADITIONAL) ATTN: BRUCE DAVIS PHONE NO : 297-842-7914 34 BUNSEN DR. SE DECISION MADE: 26-OCT-00 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACRYDERM SILVER ANTIMICROBIAL STRANDS MODEL A-020103 ACRYMED, INC. 510(k) NO: K002909(SPECIAL) ATTN: BRUCE GIBBINS PHONE NO : 503-624-9830 12232 SW GARDEN PLACE SE DECISION MADE: 13-OCT-00 PORTLAND, OR 97223 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO YASARGIL ANEURYSM CLIPS AESCULAP, INC. 510(k) NO: K002871(SPECIAL) ATTN: JOYCE THOMAS PHONE NO : 610-231-0228 3773 EXECUTIVE CENTER PARKWAY SE DECISION MADE: 13-OCT-00 CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: M2376A DEVICELINK SYSTEM, MODEL M2376A AGILENT TECHNOLOGIES, INC. 510(k) NO: K002967(SPECIAL) ATTN: MIKE HUDON PHONE NO : 978-659-3173 3000 MINUTEMAN RD. SE DECISION MADE: 18-OCT-00 ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: M2376A DEVICELINK SYSTEM AGILENT TECHNOLOGIES, INC. 510(k) NO: K003107(SPECIAL) ATTN: MIKE HUDON PHONE NO : 978-659-3173 3000 MINUTEMAN RD. SE DECISION MADE: 19-OCT-00 ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001 AIR FORCE INC 510(k) NO: K001493(TRADITIONAL) ATTN: PIERO POLICICCHIO PHONE NO : 619-399-8511 933 BUTTERNUT DRIVE SE DECISION MADE: 25-OCT-00 HOLLAND, MI 49424 510(k) STATEMENT DEVICE: DA VINCHI EEG AND EMG/EP SYSTEMS AIRSEP CORP. 510(k) NO: K000963(TRADITIONAL) ATTN: PETER WEISENBORN PHONE NO : 716-691-0202 290 CREEKSIDE DR. SE DECISION MADE: 20-OCT-00 BUFFALO, NY 14228-2070 510(k) STATEMENT DEVICE: OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION ALCON UNIVERSAL, LTD. 510(k) NO: K002589(TRADITIONAL) ATTN: MICHAEL E PFLEGER PHONE NO : 817-551-4877 6201 SOUTH FREEWAY SE DECISION MADE: 23-OCT-00 FORT WORTH, TX 76134-2099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMS SPHINCTER 800 URINARY PROSTHESIS AMERICAN MEDICAL SYSTEMS, INC. 510(k) NO: K002919(SPECIAL) ATTN: ELSA A LINKE PHONE NO : 952-930-6309 10700 BREN RD., WEST SE DECISION MADE: 03-OCT-00 MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANGIODYNAMICS SOFT-VU HYDROPHILIC COATED ANGIOGRAPHIC CATHETER ANGIODYNAMICS, INC. 510(k) NO: K001578(SPECIAL) ATTN: TERI JUCKETT PHONE NO : 518-798-1215 603 QUEENSBURY AVE. SE DECISION MADE: 13-OCT-00 QUEENSBURY, NY 12804 510(k) STATEMENT DEVICE: VINYL EXAMINATION GLOVES, POWDER FREE, BLUE COLOR ARISTA LATINDO INDUSTRIAL, LTD. P.510(k) NO: K002745(TRADITIONAL) ATTN: LINGA SUMARTA PHONE NO : 622 166 20201/195 128 JALAN KYAI HAJI MUHAMMAD SE DECISION MADE: 12-OCT-00 MANSYUR 510(k) STATEMENT JAKARTA BARAT, INDONESIA 11210 DEVICE: VINYL EXAMINATION GLOVES, POWDER FREE, VANILLA COLOR ARISTA LATINDO INDUSTRIAL, LTD. P.510(k) NO: K002746(TRADITIONAL) ATTN: LINGA SUMARTA PHONE NO : 622 166 20201/195 128 JALAN KYAI HAJI MUHAMMAD SE DECISION MADE: 11-OCT-00 MANSYUR 510(k) STATEMENT JAKARTA BARAT, INDONESIA 11210 DEVICE: TWO-LUMEN PICC WITH BLUE FLEXTIP CATHETER AND INTEGRAL NEEDLE PR ARROW INTL., INC. 510(k) NO: K003006(TRADITIONAL) ATTN: THOMAS D NICKEL PHONE NO : 610-478-3137 2400 BERNVILLE RD. SE DECISION MADE: 27-OCT-00 READING, PA 19605 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATOM INFA WARMER V-505 ATOM MEDICAL CORPORATION 510(k) NO: K002355(ABBREVIATED) ATTN: SHEILA HEMEON-HEYER PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 10-OCT-00 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP AUTOMATIC LIQUID PACKAGING, INC. 510(k) NO: K994321(TRADITIONAL) ATTN: JOHN BRDA PHONE NO : 815-338-9500 2200 LAKE SHORE DR. SE DECISION MADE: 25-OCT-00 WOODSTOCK, IL 60098 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 0.9% SODIUM CHLORIDE VASCULAT ACCESS DEVICE AVITRO LLC 510(k) NO: K000632(TRADITIONAL) ATTN: JOHN BRDA PHONE NO : 815-338-9500 2200 LAKE SHORE DRIVE SE DECISION MADE: 19-OCT-00 WOODSTOCK, IL 60098 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE AVITRO LLC, 10 AND 100 USO UNITS/ML HEPARIN SODIUM VAFD AVITRO LLC 510(k) NO: K001795(TRADITIONAL) ATTN: JOHN BRDA PHONE NO : 815-338-9500 2200 LAKE SHORE DRIVE SE DECISION MADE: 19-OCT-00 WOODSTOCK, IL 60098 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHOENIX DIGITAL EEG AXON SYSTEMS, INC. 510(k) NO: K002316(TRADITIONAL) ATTN: HOWARD BAILIN PHONE NO : 800-888-2966 400-2200 OSER AVE. SE DECISION MADE: 26-OCT-00 HAUPPAUGE, NY 11788 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUTURE WELDING SYSTEM AND KIT-(J-TIP DESIGN) AXYA MEDICAL, INC. 510(k) NO: K002557(TRADITIONAL) ATTN: HOWARD L SCHRAYER PHONE NO : 609-924-9510 100 CUMMINGS CENTER SE DECISION MADE: 06-OCT-00 SUITE 444C 510(k) SUMMARY AVAILABLE FROM FDA BEVERLY, MA 01915 DEVICE: RENU MULTIPLUS MULTI-PURPOSE DISINFECTING SOLUTION BAUSCH & LOMB, INC. 510(k) NO: K002823(TRADITIONAL) ATTN: PAUL G STAPLETON PHONE NO : 716-338-8172 1400 NORTH GOODMAN ST. SE DECISION MADE: 17-OCT-00 ROCHESTER, NY 14603-0450 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVE BAXTER HEALTHCARE CORP. 510(k) NO: K003225(SPECIAL) ATTN: MARY ELLEN SNYDER PHONE NO : 847-270-4644 RT. 120 AND WILSON ROAD SE DECISION MADE: 19-OCT-00 ROUND LAKE, IL 60073-0490 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVIA: CENTAUR AND ACS: 180 CPSA ASSAY BAYER CORP. 510(k) NO: K002376(TRADITIONAL) ATTN: WILLIAM J PIGNATO PHONE NO : 508-359-3825 63 NORTH ST. SE DECISION MADE: 26-OCT-00 MEDFIELD, MA 02052-1688 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BAYLIS PAIN MANAGEMENT PROBE/PMP-20-145 AND BAYLIS PAIN MANAGEME BAYLIS MEDICAL CO., INC. 510(k) NO: K002389(TRADITIONAL) ATTN: KRIS SHAH PHONE NO : 905 602 4875 5160 EXPLORER DRIVE, UNIT 37 SE DECISION MADE: 23-OCT-00 MISSISSAUGA, CANADA L4W-4T7 510(k) STATEMENT DEVICE: PARAGON CZE 2000 CAPILLARY ELECTROPHORESIS SYSTEM AND BUFFER-100 BECKMAN COULTER, INC. 510(k) NO: K002799(SPECIAL) ATTN: ANNETTE HELLIE PHONE NO : 714-993-8767 200 SOUTH KRAEMER BLVD. SE DECISION MADE: 05-OCT-00 BREA, CA 92822-8000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER BECKMAN COULTER, INC. 510(k) NO: K002905(TRADITIONAL) ATTN: MARA CALER PHONE NO : 858-621-4583 7330 CARROLL ROAD SE DECISION MADE: 19-OCT-00 SAD DIEGO, CA 92196-9006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BVI SLING BIO-VASCULAR, INC. 510(k) NO: K002233(TRADITIONAL) ATTN: DAISY P SIN PHONE NO : 651-603-5203 2575 UNIVERSITY AVE., STE.180 SE DECISION MADE: 13-OCT-00 ST. PAUL, MN 55114-1024 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOLYTE 2000 NA+,K+,CL-/LI+ELECTROLYTE ANALYZER BIOCARE CORP. 510(k) NO: K002855(TRADITIONAL) ATTN: PAUL W MCDONALD PHONE NO : 781-894-0800 200 PROSPECT STREET SE DECISION MADE: 12-OCT-00 WALTHAM, MA 02454 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOCHECK TESTOSTERONE EIA, MODEL BC-1115 BIOCHECK, INC. 510(k) NO: K002294(TRADITIONAL) ATTN: ROBIN J HELLEN PHONE NO : 818-709-5646 9418 LASAINE AVE SE DECISION MADE: 02-OCT-00 NORTHRIDGE, CA 91325 510(k) STATEMENT DEVICE: WUJIN #3 TIBIAL NAIL BIOLOGICALLY ORIENTED PROSTHESES 510(k) NO: K002325(TRADITIONAL) ATTN: ANGENA PAREKH PHONE NO : 810-982-7777 17 SEVENTEENTH ST. SE DECISION MADE: 30-OCT-00 PORT HURON, MI 48060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192 BIOMERIEUX, INC. 510(k) NO: K001460(TRADITIONAL) ATTN: JANET CONNOLLY PHONE NO : 781-871-4442 1022 HINGHAM STREET SE DECISION MADE: 04-OCT-00 ROCKLAND, MA 02370 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BROOKER TIBIA NAILS BIOMET ORTHOPEDICS, INC. 510(k) NO: K002057(TRADITIONAL) ATTN: PATRICIA SANDBORN BERES PHONE NO : 219-267-6639 P.O. BOX 587 SE DECISION MADE: 04-OCT-00 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BROOKER FEMORAL NAILS BIOMET ORTHOPEDICS, INC. 510(k) NO: K002278(TRADITIONAL) ATTN: PATRICIA SANDBORN BERES PHONE NO : 219-269-6639 P.O. BOX 587 SE DECISION MADE: 23-OCT-00 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LACTOSORB PUSH SCREW BIOMET, INC. 510(k) NO: K002423(TRADITIONAL) ATTN: TRACY BICKEL PHONE NO : 219-372-1761 56 EAST BELL DRIVE SE DECISION MADE: 20-OCT-00 WARSAW, IN 46582 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASCENT XXL CLOSED BOX FEMORAL COMPONENT BIOMET, INC. 510(k) NO: K002772(SPECIAL) ATTN: MICHELLE L MCKINLEY PHONE NO : 219-372-1644 AIRPORT INDUSTRIAL PARK, SE DECISION MADE: 04-OCT-00 P.O.BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46580 DEVICE: BIOMET BI-POLAR SHOULDER SYSTEM BIOMET, INC. 510(k) NO: K002998(SPECIAL) ATTN: TRACY J BICKE; PHONE NO : 219-372-1761 AIRPORT INDUSTRIAL PARK SE DECISION MADE: 06-OCT-00 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: MODIFICATION TO BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM BIOPLATE, INC. 510(k) NO: K002879(SPECIAL) ATTN: ERIC V HOHENSTEIN PHONE NO : 323-549-9500 6911 MELROSE AVE. SE DECISION MADE: 05-OCT-00 LOS ANGELES, CA 90038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOPRO, NITRILON, CORRECT TOUCH- NITRILE POWDERED EXAMINATION GL BIOPRO (M) SDN BHD 510(k) NO: K994276(TRADITIONAL) ATTN: JAMES H LALE PHONE NO : 603 376 1386 LOT14, PT.4204 LINGKARN SULTAN SE DECISION MADE: 20-OCT-00 HISHAMUDDIN, NORTH PORT INDU. 510(k) STATEMENT PORT KLANG, MALAYSIA 42000 DEVICE: BIOPRO, NITRILE, CORRECT TOUCH NITRILE POWDER FREE EXAMINATION G BIOPRO (M) SDN BHD 510(k) NO: K994281(TRADITIONAL) ATTN: JAMES H LALE PHONE NO : 603 376 1390 LOT14, PT.4204 LINGKARN SULTAN SE DECISION MADE: 20-OCT-00 HISHAMUDDIN, NORTH PORT INDU. 510(k) STATEMENT PORT KLANG, MALAYSIA 42000 DEVICE: NIR BILLIARY STENT SYSTEM; MARSHAL BALLOON DILATATION CATHETER BOSTON SCIENTIFIC CORP. 510(k) NO: K002133(TRADITIONAL) ATTN: JODI LYNN GREENNIZEN PHONE NO : 508-652-5008 ONE BOSTON SCIENTIFIC PLACE SE DECISION MADE: 12-OCT-00 NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RAPID EXCHANGE TAPERTOME BOSTON SCIENTIFIC CORP. 510(k) NO: K002802(SPECIAL) ATTN: CAROL J HOLLOWAY PHONE NO : 508-650-8514 ONE BOSTON SCIENTIFIC PLACE SE DECISION MADE: 05-OCT-00 NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLUCANPRO CREAM BRENNEN MEDICAL, INC. 510(k) NO: K002077(TRADITIONAL) ATTN: PHILLIP LAWIN PHONE NO : 651-429-7413 1290 HAMMOND RD. SE DECISION MADE: 02-OCT-00 ST. PAUL, MN 55110 510(k) STATEMENT DEVICE: BETA GLUCAN GEL (MACROPRO GEL) BRENNEN MEDICAL, INC. 510(k) NO: K002078(TRADITIONAL) ATTN: PHILLIP LAWIN PHONE NO : 651-429-7413 1290 HAMMOND RD. SE DECISION MADE: 02-OCT-00 ST. PAUL, MN 55110 510(k) STATEMENT DEVICE: BARD MEMOTHERM COVERED ESOPHAGEAL STENT, MODEL MULTIPLE C.R. BARD, INC. 510(k) NO: K002094(TRADITIONAL) ATTN: MARION GORDON PHONE NO : 978-262-4867 129 CONCORD RD., BLDG. 3 SE DECISION MADE: 06-OCT-00 BILLERICA, MA 01821-7031 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPOSIX E/X MESH C.R. BARD, INC. 510(k) NO: K002684(TRADITIONAL) ATTN: RUTH C FORSTADT PHONE NO : 401-463-7000 100 SOCKANOSSETT CROSSROAD SE DECISION MADE: 11-OCT-00 CANSTON, RI 02920 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHROMAGEN V2.0 HAPLOSCOPIC SYSTEM & COLOR VISION ENHANCEMENT SOF CANTOR & SILVER LTD. 510(k) NO: K994320(TRADITIONAL) ATTN: MARTIN DALSING PHONE NO : 970-243-5490 623 GLACIER DRIVE SE DECISION MADE: 20-OCT-00 GRAND JUNCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CEDARA CARDIOLOGY VIEWER, CARDIOLOGY ARCHIVE VIEWER, CARDIOLOGY CEDARA SOFTWARE CORPORATION 510(k) NO: K002590(TRADITIONAL) ATTN: CAROL NAKAGAWA PHONE NO : 905 672 2100 6509 AIRPORT RD. SE DECISION MADE: 31-OCT-00 MISSISSAUGA, ONTARIO, CANADA L4V 1510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CERALAS G15 532NM FREQUENCY DOUBLED ND:YAG LASER, MODEL G1-G15 CERAMOPTEC, INC. 510(k) NO: K002296(TRADITIONAL) ATTN: CAROL J MORELLO PHONE NO : 413-525-0600 515 SHAKER ROAD SE DECISION MADE: 02-OCT-00 EAST LONGMEADOW, MA 01028 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CIV-FLEX HOLSTER COVER, MODEL STERILE, LATEX-FREE CIVCO MEDICAL INSTRUMENTS CO., INC510(k) NO: K002546(TRADITIONAL) ATTN: J. WILLIAM JONES PHONE NO : 319-656-4447 102 FIRST ST. SOUTH SE DECISION MADE: 31-OCT-00 KALONA, IA 52247 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUTOSTAT II ENA-6 PROFILE ELISA COGENT DIAGNOTICS LTD. 510(k) NO: K003054(TRADITIONAL) ATTN: DANIELLE KNIGHT PHONE NO : 714-933-3000 PENTLANDS SCIENCE PARK SE DECISION MADE: 13-OCT-00 BUSH LOAN, PENICUIK 510(k) STATEMENT MIDLOTHIAN, SCOTLAND, UNITED KINGDOM EH26 OPL DEVICE: AUTOSTAT II ENA-4 PROFILE ELISA COGENT DIAGNOTICS LTD. 510(k) NO: K003057(TRADITIONAL) ATTN: DANIELLE KNIGHT PHONE NO : 714-933-3000 PENTLANDS SCIENCE PARK SE DECISION MADE: 13-OCT-00 BUSH LOAN, PENICUIK 510(k) STATEMENT MIDLOTHIAN, SCOTLAND, UNITED KINGDOM EH26 OPL DEVICE: FOCUS COMPUTERIZED MEDICAL SYSTEMS, INC.510(k) NO: K002147(TRADITIONAL) ATTN: MICHAEL A PARSONS PHONE NO : 314-993-0003 1145 CORPORATE LAKE DR. SE DECISION MADE: 13-OCT-00 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA ST. LOUIS, MO 63132-1716 DEVICE: GUNTHER TULIP VENA CAVA MREYE FILTER SET COOK, INC. 510(k) NO: K000855(TRADITIONAL) ATTN: MARY GOSSARD PHONE NO : 812-339-2235 925 SOUTH CURRY PIKE SE DECISION MADE: 18-OCT-00 P.O. BOX 489 510(k) SUMMARY AVAILABLE FROM FDA BLOOMINGTON, IN 47402 DEVICE: CORDIS SLALOM PTA BALLOON CATHETER CORDIS CORP. 510(k) NO: K003159(SPECIAL) ATTN: CHUCK RYAN PHONE NO : 908-412-7446 7 POWDERHORN DRIVE SE DECISION MADE: 30-OCT-00 WARREN, NJ 07059 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SWISSPLUS IMPLANT SYSTEM, MODEL SPWB 8,10,12,14/OPH20/SMPR, SPB CORE-VENT CORP. 510(k) NO: K002188(TRADITIONAL) ATTN: WILL FISHER PHONE NO : 702-253-1344 4630 SOUTH ARVILLE, SUITE D SE DECISION MADE: 30-OCT-00 LAS VEGAS, NV 89103 510(k) STATEMENT DEVICE: BIOMESH P1 AND BIOMESH PLUG AND PATCH COUSIN BIOTECH S.A.R.L 510(k) NO: K002479(TRADITIONAL) ATTN: HOWARD M HOLSTEIN PHONE NO : 202-637-5813 555 THIRTEENTH STREET, N.W. SE DECISION MADE: 19-OCT-00 WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECAT PET SCANNER CTI PET SYSTEMS, INC. 510(k) NO: K002715(TRADITIONAL) ATTN: WILLIAM SKREMSKY PHONE NO : 865-218-2522 810 INNOVATION DR. SE DECISION MADE: 31-OCT-00 KNOXVILLE, TN 37932-2571 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CURON CONTROL MODULE ELECTROSURGICAL GENERATOR AND ACCESSORIES, CURON MEDICAL, INC. 510(k) NO: K002898(SPECIAL) ATTN: THOMAS C WEHMAN PHONE NO : 408-733-9910 735 PALOMAR AVENUE SE DECISION MADE: 17-OCT-00 SUNNYVALE, CA 94086 510(k) STATEMENT DEVICE: GLOBAL SPINAL FIXATION SYSTEM D.K.M. CO.,LTD. 510(k) NO: K001668(TRADITIONAL) ATTN: ANDREW PAENG PHONE NO : 573-225-7700 P.O. BOX 3415 SE DECISION MADE: 19-OCT-00 ST. LOUIS, MO 63143 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMIT 2000 VALPROIC ACID ASSAY, EMIT 2000 VALPROIC ACID CALIBRATO DADE BEHRING, INC. 510(k) NO: K002551(TRADITIONAL) ATTN: PAUL L ROGERS PHONE NO : 408-239-2309 3403 YERBA BUENA ROAD SE DECISION MADE: 11-OCT-00 P.O. BOX 49013 510(k) SUMMARY AVAILABLE FROM FDA SAN JOSE, CA 95161-9013 DEVICE: N PROTEIN STANDARD SL DADE BEHRING, INC. 510(k) NO: K002804(TRADITIONAL) ATTN: REBECCA S AYASH PHONE NO : 302-631-6276 GLASGOW SITE SE DECISION MADE: 05-OCT-00 P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714-6101 DEVICE: EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL; EMIT TOX ECETAMINOP DADE BEHRING, INC. 510(k) NO: K002974(TRADITIONAL) ATTN: PAUL L ROGERS PHONE NO : 408-239-2309 3403 YERBA BUENA ROAD SE DECISION MADE: 11-OCT-00 SAN JOSE, CA 95161-9013 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 34CC; MODIFICATION T DATASCOPE CORP. 510(k) NO: K002949(SPECIAL) ATTN: JOANNE WOLF PHONE NO : 973-244-6100 15 LAW DR. SE DECISION MADE: 20-OCT-00 FAIRFIELD, NJ 07004-0011 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: S/5 COMPACT ANESTHESIA MONITOR WITH S-00A05, S-00A06. L-00A07, L DATEX-OHMEDA, INC. 510(k) NO: K002478(TRADITIONAL) ATTN: JOEL C KENT PHONE NO : 978-640-0460 3 HIGHWOOD DR. SE DECISION MADE: 05-OCT-00 TEWKSBURY, MA 01876 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEPILASE YAGLASE ND:YAG LASER SYSTEM AND ACCESSORIES DEPILASE GROUP LTD. 510(k) NO: K001990(TRADITIONAL) ATTN: MARIO LUCA RUSSO PHONE NO : 440 207 8496120 12 ST. JAMES'S SQUARE SE DECISION MADE: 23-OCT-00 LONDON SW1 Y 4RB, UNITED KINGDOM S510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS DEPUY ORTHOPAEDICS, INC. 510(k) NO: K002883(SPECIAL) ATTN: CHERYL K HASTINGS PHONE NO : 219-371-4901 700 ORTHOPAEDIC DR. SE DECISION MADE: 13-OCT-00 P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0988 DEVICE: MODIFICATION TO EBI ANTERIOR CERVICAL PLATE SYSTEM EBI, L.P. 510(k) NO: K002980(SPECIAL) ATTN: PATRICIA FLOOD PHONE NO : 973-299-9022 100 INTERPACE PKWY. SE DECISION MADE: 23-OCT-00 PARSIPPANY, NJ 07054-1079 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WACKERS-LIU CQ SOFTWARE ECLIPSE SYSTEMS INC. 510(k) NO: K002229(TRADITIONAL) ATTN: ROSINA ROBINSON PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 20-OCT-00 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEG EEMAGINE MEDICAL IMAGING SOLUTIONS510(k) NO: K002631(TRADITIONAL) ATTN: SCOTT PEASE PHONE NO : 262-363-5546 W306 D8345 CHESNUT DRIVE SE DECISION MADE: 23-OCT-00 MUKWONAGO, WI 53149 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL ELECTRO MEDICAL SYSTEMS SA 510(k) NO: K002484(TRADITIONAL) ATTN: SHEILA HEMEON-HEYER PHONE NO : 508-643-0460 49 PLAIN STREET SE DECISION MADE: 04-OCT-00 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO ISOBAR SPINAL SYSTEM ENCORE ORTHOPEDICS, INC. 510(k) NO: K002959(SPECIAL) ATTN: JOANNA DROEGE PHONE NO : 512-834-6255 9800 METRIC BLVD. SE DECISION MADE: 16-OCT-00 AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDIUS ENDOSCOPIC ACCESS SYSTEM ENDIUS INC. 510(k) NO: K002437(TRADITIONAL) ATTN: SUSAN FINNERAN PHONE NO : 508-643-0983 23 WEST BACON ST. SE DECISION MADE: 02-OCT-00 PLAINVILLE, MA 02762 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOCARE PERCUTANEOUS ACCESS SET ENDOCARE, INC. 510(k) NO: K002396(TRADITIONAL) ATTN: VINCENT CUTARELLI PHONE NO : 949-595-5424 7 STUDEBAKER SE DECISION MADE: 13-OCT-00 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEADBAND FOR BAHA ENTIFIC MEDICAL SYSTEMS INC. 510(k) NO: K002913(TRADITIONAL) ATTN: CONSTANCE G BUNDY PHONE NO : 612-571-1976 6470 RIVERVIEW TERRACE SE DECISION MADE: 17-OCT-00 MINNEAPOLIS, MN 55432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELRAN 01 SYSTEM ENVISION ADVANCED MEDICAL SYSTEM L510(k) NO: K002431(ABBREVIATED) ATTN: GERARD J PRUD'HOMME PHONE NO : 202-637-5735 555 THIRTEENTH STREET, N.W. SE DECISION MADE: 24-OCT-00 WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EUPALAMUS DEFLECTABLE STYLET, MODEL 01545 EUPALAMUS, LLC 510(k) NO: K002534(TRADITIONAL) ATTN: ANNE LAURITZEN PHONE NO : 310-471-6289 3411 MANDEVILLE CANYON ROAD SE DECISION MADE: 18-OCT-00 BRENTWOOD, CA 90049 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PLASMAKINETIC GENERATOR EVEREST MEDICAL CORP. 510(k) NO: K003060(SPECIAL) ATTN: DAVID KAY PHONE NO : 44 029 20776300 FORTRAN ROAD, SE DECISION MADE: 31-OCT-00 ST. MELLONS, CARDIFF, UNITED KINGD510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EEG SPIKE AND EVENT DETECTOR MODULE EXCEL TECH. LTD. 510(k) NO: K002332(TRADITIONAL) ATTN: DEBBIE DAVY PHONE NO : 905 829 5300 2568 BRISTOL CIRCLE SE DECISION MADE: 06-OCT-00 OAKVILLE, ONTARIO, CANADA L6H 5S1510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIRECT CROWN FLEXIBLE DIMENSIONS LLC 510(k) NO: K001884(TRADITIONAL) ATTN: CAROL PATTERSON PHONE NO : 949-462-0900 21911 ERIE LANE SE DECISION MADE: 25-OCT-00 LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLUOROSCAN PROFILE, MODEL TCA 4 PLUS; FLUOROSCAN PROFILE IQ, MOD FLUORO SCAN IMAGING SYSTEMS, INC. 510(k) NO: K002198(TRADITIONAL) ATTN: WILLIAM J ENGEL PHONE NO : 847-564-5400 650-B ANTHONY TRAIL SE DECISION MADE: 17-OCT-00 NORTHBROOK, IL 60062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER FONAR CORP. 510(k) NO: K002490(TRADITIONAL) ATTN: LUCIANO BONANNI PHONE NO : 631-694-2929 110 MARCUS DR SE DECISION MADE: 03-OCT-00 MELVILLE, NY 11747 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SEEDNET, MODEL EP6T5, EP5E5 GALIL MEDICAL LTD. 510(k) NO: K003065(SPECIAL) ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794 555 THIRTEEN ST. SE DECISION MADE: 31-OCT-00 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER GAMBRO HEALTHCARE 510(k) NO: K994390(TRADITIONAL) ATTN: JEFFREY R SHIDEMAN PHONE NO : 612-835-4018 1185 OAK ST. SE DECISION MADE: 26-OCT-00 LAKEWOOD, CO 80215 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOLAR SPO2 MODULE WITH MASIMO SET GE MARQUETTE MEDICAL SYSTEMS, INC.510(k) NO: K002957(SPECIAL) ATTN: DAVID WAHLIG PHONE NO : 414-362-2090 8200 WEST TOWER AVE. SE DECISION MADE: 18-OCT-00 MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIGTHSPEED 3.0 CT SCANNER SYSTEM GE MEDICAL SYSTEM 510(k) NO: K002978(TRADITIONAL) ATTN: LARRY A KROGER PHONE NO : 262-544-3894 16800 RYERSON ROAD SE DECISION MADE: 10-OCT-00 NEW BERLIN, WI 53151 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIGNA MFO/I MAGNETIC RESONANCE SYSTEM GE MEDICAL SYSTEMS 510(k) NO: K002611(TRADITIONAL) ATTN: LARRY A KROGER PHONE NO : 262-544-3894 P.O. BOX 414, W-709 SE DECISION MADE: 31-OCT-00 MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THERMAL CAUTERY UNIT, MODEL 150 GEIGER MEDICAL TECHNOLOGIES, INC. 510(k) NO: K002341(TRADITIONAL) ATTN: JOHN BOTTJER PHONE NO : 949-240-7584 24040 CAMINO DEL AVION, A-195 SE DECISION MADE: 23-OCT-00 MONARCH BEACH, CA 92629 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REUSABLE CANNULA GENICON, LC 510(k) NO: K002542(TRADITIONAL) ATTN: GARY HABERLAND PHONE NO : 407-273-7619 573 WATERSCAPE WAY SE DECISION MADE: 23-OCT-00 ORLANDO, FL 32828 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GEUDER INJECTOR FOR MORCHER CAPSULAR TENSION RING GEUDER GMBH 510(k) NO: K001125(TRADITIONAL) ATTN: HILLARD W WELCH PHONE NO : 508-771-6777 344 ANNABELLE POINT ROAD SE DECISION MADE: 04-OCT-00 CENTERVILLE, MA 02632-2402 510(k) STATEMENT DEVICE: CRANIOCAP GILLETTE CHILDREN'S SPECIALTY HEAL510(k) NO: K000861(TRADITIONAL) ATTN: LINDA VALERI PHONE NO : 651-229-3808 1785 GOLD COURT SE DECISION MADE: 30-OCT-00 EAGAN, MN 55122 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VACUETTE WITH PPACK GREINER VACUETTE NORTH AMERICA, IN510(k) NO: K002777(TRADITIONAL) ATTN: JUDI SMITH PHONE NO : 410-313-8003 P.O. BOX 6581 SE DECISION MADE: 05-OCT-00 ELLICOTT CITY, MD 21042-0581 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOVANCE DUALPASS TEAR-AWAY SHEATH INTRODUCER GUIDANT CARDIAC AND VASCULAR SURGE510(k) NO: K002676(TRADITIONAL) ATTN: KRISTEN HONL PHONE NO : 650-470-6200 1525 O'BRIEN DR. SE DECISION MADE: 30-OCT-00 MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DYNALINK BILIARY SELF-EXPANDING STENT SYSTEM GUIDANT CORP. 510(k) NO: K002143(TRADITIONAL) ATTN: SUSAN SILAVIN, PH.D. PHONE NO : 408-845-3127 3200 LAKESIDE DR. SE DECISION MADE: 12-OCT-00 SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AB CARDIETTE DAEDALUS VIEW BASE AND AB CARDIETTTE DAEDALUS VIEW H&C MEDICAL DEVICES SPA 510(k) NO: K002074(TRADITIONAL) ATTN: ATTILIO CASTELLI PHONE NO : 046-385-0125 VIA PISA 250 SE DECISION MADE: 04-OCT-00 20099 SESTO SAN GIOVANNI 510(k) SUMMARY AVAILABLE FROM FDA MILAN, ITALY DEVICE: HARALD NORDIN CARBONITE CARBON FIBER COMPOSITE DENTAL POST HARALD NORDIN S.A 510(k) NO: K003219(SPECIAL) ATTN: JAMES DELANEY PHONE NO : 978-371-0066 100 MAIN STREET; SUITE 120 SE DECISION MADE: 25-OCT-00 CONCORD, MA 01742 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HARALD NORDIN GLASSIX GLASS FIBER COMPOSITE DENTAL POST HARALD NORDIN S.A 510(k) NO: K003221(SPECIAL) ATTN: JAMES DELANEY PHONE NO : 978-371-0066 100 MAIN STREET; SUITE 120 SE DECISION MADE: 25-OCT-00 CONCORD, MA 01742 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HARDY DISK CEFTIZOXIME, 30MCG HARDY DIAGNOSTICS 510(k) NO: K002367(TRADITIONAL) ATTN: MELISSA M TRAYLOR PHONE NO : 805-346-2766 1430 WEST MCCOY LANE SE DECISION MADE: 26-OCT-00 SANTA MARIA, CA 93455 510(k) STATEMENT DEVICE: HARDYDISK STREPTOMYCIN, 300MCG HARDY DIAGNOSTICS 510(k) NO: K002368(TRADITIONAL) ATTN: MELISSA M TRAYLOR PHONE NO : 805-346-2766 1430 WEST MCCOY LANE SE DECISION MADE: 25-OCT-00 SANTA MARIA, CA 93455 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HARDYDISK GENTAMICIN, 120MCG HARDY DIAGNOSTICS 510(k) NO: K002369(TRADITIONAL) ATTN: MELISSA M TRAYLOR PHONE NO : 805-346-2766 1430 WEST MCCOY LANE SE DECISION MADE: 26-OCT-00 SANTA MARIA, CA 93455 510(k) STATEMENT DEVICE: HARDYDISK CEFUROXIME, 30MCG HARDY DIAGNOSTICS 510(k) NO: K002656(TRADITIONAL) ATTN: MELISSA M TRAYLOR PHONE NO : 805-346-2766 1430 WEST MCCOY LANE SE DECISION MADE: 25-OCT-00 SANTA MARIA, CA 93455 510(k) STATEMENT DEVICE: HARDYDISK LOMEFLOXACIN, 10MCG HARDY DIAGNOSTICS 510(k) NO: K002660(TRADITIONAL) ATTN: MELISSA M TRAYLOR PHONE NO : 805-346-2766 1430 WEST MCCOY LANE SE DECISION MADE: 26-OCT-00 SANTA MARIA, CA 93455 510(k) STATEMENT DEVICE: HARDYDISK CEFOTETAN, 30MCG HARDY DIAGNOSTICS 510(k) NO: K002661(TRADITIONAL) ATTN: MELISSA M TRAYLOR PHONE NO : 805-346-2766 1430 WEST MCCOY LANE SE DECISION MADE: 26-OCT-00 SANTA MARIA, CA 93455 510(k) STATEMENT DEVICE: HARDYDISK NETILMICIN, 30MCG HARDY DIAGNOSTICS 510(k) NO: K002663(TRADITIONAL) ATTN: MELISSA M TRAYLOR PHONE NO : 805-346-2766 1430 WEST MCCOY LANE SE DECISION MADE: 19-OCT-00 SANTA MARIA, CA 93455 510(k) STATEMENT DEVICE: HARDYDISK LEVOFLOXACIN, 5MCG HARDY DIAGNOSTICS 510(k) NO: K002664(TRADITIONAL) ATTN: MELISSA M TRAYLOR PHONE NO : 805-346-2766 1430 WEST MCCOY LANE SE DECISION MADE: 26-OCT-00 SANTA MARIA, CA 93455 510(k) STATEMENT DEVICE: CLA KIT (CONTINUOUS LOCAL ANESTHESIA), MODEL 551-17, 551-10, 551 HDC CORP. 510(k) NO: K994059(TRADITIONAL) ATTN: JAMES ABILLA PHONE NO : 408-954-1909 2109 O'TOOLE AVE. SE DECISION MADE: 13-OCT-00 SAN JOSE, CA 95131 510(k) STATEMENT DEVICE: HL168B HEALTH & LIFE CO., LTD. 510(k) NO: K002882(SPECIAL) ATTN: PAUL YANG PHONE NO : 886 2 32349600 6F,NO. 407, CHUNG SHAN RD. SE DECISION MADE: 13-OCT-00 SEC.02, CHUNG HO CITY 510(k) STATEMENT TAIPEI HSIEN, CHINA (TAIWAN) DEVICE: RAICHEM PHOSPORUS REAGENT HEMAGEN DIAGNOSTICS, INC. 510(k) NO: K003012(SPECIAL) ATTN: JOSE A MONTANEZ PHONE NO : 443-367-5518 9033 RED BRANCH ROAD SE DECISION MADE: 25-OCT-00 COLUMBIA, MD 21045-2105 510(k) STATEMENT DEVICE: NARKOMAT, MODEL 2000 HEYER AMERICA, INC. 510(k) NO: K000995(TRADITIONAL) ATTN: ART WARD PHONE NO : 813-645-2855 3234 ELLA LANE SE DECISION MADE: 11-OCT-00 NEW PORT RICHEY, FL 34655 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HITACHI ALTAIRE HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K002420(ABBREVIATED) ATTN: DOUGLAS THISTLETHWAITE PHONE NO : 330-425-1313 1959 SUMMIT COMMERCE PARK SE DECISION MADE: 17-OCT-00 TWINSBURG, OH 44087-2371 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUREONE INSULIN SYRINGE HOSUK CO., LTD. 510(k) NO: K002921(TRADITIONAL) ATTN: Y. H KIM PHONE NO : 011 82 438830411 52-6 DUKJEONG-RI, SAMSUNG-MYUN SE DECISION MADE: 18-OCT-00 UMSUNG-GUN, CHUNGCHEONG, REPUBLIC 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XIA SPINE SYSTEM HOWMEDICA OSTEONICS CORP. 510(k) NO: K002505(SPECIAL) ATTN: MARY-CATHERINE DILLON PHONE NO : 201-760-8117 59 ROUTE 17 SE DECISION MADE: 05-OCT-00 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XIA SPINE SYSTEM HOWMEDICA OSTEONICS CORP. 510(k) NO: K002858(SPECIAL) ATTN: MARY-CATHERINE DILLON PHONE NO : 201-760-8117 59 ROUTE 17 SE DECISION MADE: 13-OCT-00 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BULL'S-EYE DISPOSABLE NEEDLE RECAPPING AID HUNTER RESEARCH LABORATORIES, INC.510(k) NO: K002213(TRADITIONAL) ATTN: BARBARA PEDIGO PHONE NO : 303-744-1989 1541 SOUTH VINE ST. SE DECISION MADE: 03-OCT-00 DENVER, CO 80210 510(k) STATEMENT DEVICE: I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300 I-STAT CORP. 510(k) NO: K001387(TRADITIONAL) ATTN: PAUL VANDERWERF PHONE NO : 609-469-0242 104 WINDSOR CENTER DR. SE DECISION MADE: 05-OCT-00 EAST WINDSOR, NJ 08520 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK IC-USA, INC. 510(k) NO: K001972(TRADITIONAL) ATTN: CAROL PATTERSON PHONE NO : 949-462-0900 21911 ERIE LANE SE DECISION MADE: 27-OCT-00 LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BURR HOLE COVER, MODEL XX IMAGE-GUIDED NEUROLOGICS, INC. 510(k) NO: K001096(TRADITIONAL) ATTN: DAVID M LEE PHONE NO : 321-757-8990 2290 EAU GALLIE BLVD. SE DECISION MADE: 25-OCT-00 MELBOURNE, FL 32935 510(k) STATEMENT DEVICE: NAVIGUS PEEL AWAY INTRODUCER IMAGE-GUIDED NEUROLOGICS, INC. 510(k) NO: K002330(TRADITIONAL) ATTN: DAVID M LEE PHONE NO : 321-757-8990 2290 EAU GALLIE BLVD. SE DECISION MADE: 18-OCT-00 MELBOURNE, FL 32935 510(k) STATEMENT DEVICE: PINS AND WIRES IMPLANT RESOURCE, INC. 510(k) NO: K002125(TRADITIONAL) ATTN: AL LIPPINCOTT PHONE NO : 952-492-5858 3150 E. 200TH STREET SE DECISION MADE: 11-OCT-00 PRIOR LAKE, MN 55372 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMPOAID IMPOAID, INC. 510(k) NO: K000730(TRADITIONAL) ATTN: ELAIN DUNCAN PHONE NO : 715-549-6035 P.O. BOX 560 SE DECISION MADE: 19-OCT-00 STILLWATER, MN 55082 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSIGHT 4000 ENDOSCOPE INSIGHT INSTRUMENTS MFG., INC. 510(k) NO: K000252(TRADITIONAL) ATTN: K. PETER LULOH PHONE NO : 407-324-2727 5400 SOUTH BRYANT AVE. SE DECISION MADE: 17-OCT-00 SANFORD, FL 32773 510(k) STATEMENT DEVICE: COALIZA PROTEIN S-FREE INSTRUMENTATION LABORATORY CO. 510(k) NO: K002467(TRADITIONAL) ATTN: CAROL MARBLE PHONE NO : 781-861-4467 113 HARTWELL AVE. SE DECISION MADE: 13-OCT-00 LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTERPORE CROSS ANTERIOR CERVICAL PLATE SYSTEM INTERPORE CROSS INTL. 510(k) NO: K002592(TRADITIONAL) ATTN: PROSIE REY-FESSLER PHONE NO : 949-453-3200 181 TECHNOLOGY DR. SE DECISION MADE: 06-OCT-00 IRVINE, CA 92618-2402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VENTURE IDD OXYGEN CONSERVING DEVICE IDD 20EX AND 50EX INVACARE CORP. 510(k) NO: K002284(TRADITIONAL) ATTN: EDWARD A KROLL PHONE NO : 440-329-6595 ONE INVACARE WAY SE DECISION MADE: 24-OCT-00 ELYRIA, OH 44036-2125 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRANSQ3 IOMED, INC. 510(k) NO: K001522(TRADITIONAL) ATTN: W. TIM MILLER PHONE NO : 801-975-1191 3385 WEST 1820 SOUTH SE DECISION MADE: 18-OCT-00 SALT LAKE CITY, UT 84104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JEL BIOS PURE J.F. JELENKO & CO., INC. 510(k) NO: K002645(TRADITIONAL) ATTN: RAPHAEL JUDKINS PHONE NO : 914-273-8600 99 BUSINESS PARK DR. SE DECISION MADE: 19-OCT-00 ARMONK, NY 10504 510(k) STATEMENT DEVICE: EQUITY JENSEN INDUSTRIES, INC. 510(k) NO: K002826(ABBREVIATED) ATTN: JOHN SLANSKI PHONE NO : 203-239-2090 50 STILLMAN RD. SE DECISION MADE: 24-OCT-00 NORTH HAVEN, CT 06473 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EZ-LIGHT 4000 SERIES MANUAL WHEELCHAIR JIANGSU INTCO MEDICAL EQUIPMENT & 510(k) NO: K002669(TRADITIONAL) ATTN: JAMES CHU PHONE NO : 909-548-4828 12390 EAST END AVENUE SE DECISION MADE: 11-OCT-00 CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EZ-TRAVELER 3000 SERIES MANUAL WHEELCHAIR JIANGSU INTCO MEDICAL EQUIPMENT & 510(k) NO: K002670(TRADITIONAL) ATTN: JAMES CHU PHONE NO : 909-548-4828 12390 EAST END AVENUE SE DECISION MADE: 11-OCT-00 CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EZ-TRAVELER 2500 SERIES MANUAL WHEELCHAIR JIANGSU INTCO MEDICAL EQUIPMENT & 510(k) NO: K002671(TRADITIONAL) ATTN: JAMES CHU PHONE NO : 909-548-4828 12390 EAST END AVENUE SE DECISION MADE: 11-OCT-00 CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EZ-COMFORT TRANSPORTER 2000 SERIES JIANGSU INTCO MEDICAL EQUIPMENT & 510(k) NO: K002673(TRADITIONAL) ATTN: JAMES CHU PHONE NO : 909-548-4828 12390 EAST END AVENUE SE DECISION MADE: 11-OCT-00 CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELS CANNULA (KIT), MODEL M1210-88,M1510-88 JOSTRA AG 510(k) NO: K002857(TRADITIONAL) ATTN: KATHLEEN JOHNSON PHONE NO : 302-454-9959 2035 SUNSET LAKE ROAD SE DECISION MADE: 05-OCT-00 NEWARK, DE 19702 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: K-ASSAY HIGH SENSITIVE CRP(2) FOR THE BECKMAN COULTER IMMAGE KAMIYA BIOMEDICAL CO. 510(k) NO: K002558(SPECIAL) ATTN: COLIN GETTY PHONE NO : 206-575-8068 910 INDUSTRY DR. SE DECISION MADE: 25-OCT-00 SEATTLE, WA 98188-3412 510(k) STATEMENT DEVICE: KSEA VASCULAR FIBERSCOPES KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K001408(TRADITIONAL) ATTN: KEVIN KENNAN PHONE NO : 310-410-2769 600 CORPORATE POINTE SE DECISION MADE: 30-OCT-00 CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KSEA UNIMAT 12 KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K002700(TRADITIONAL) ATTN: KEVIN KENNAN PHONE NO : 310-410-2769 600 CORPORATE POINTE SE DECISION MADE: 18-OCT-00 CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KSEA NEURO-FIBERSCOPE KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K002788(TRADITIONAL) ATTN: KEVIN KENNAN PHONE NO : 310-410-2769 600 CORPORATE POINTE SE DECISION MADE: 23-OCT-00 CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRACK 1.0 & 1.5 MM SYSTEMS-TISSUE REGENERATION BY ALVEOLAR CALLU KLS-MARTIN L.P. 510(k) NO: K002152(TRADITIONAL) ATTN: ART WARD PHONE NO : 813-645-2855 3234 ELLA LANE SE DECISION MADE: 10-OCT-00 NEW PORT RICHEY, FL 34655 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RESUSCI INFLATE-A-SHIELD CPR BARRIER LAERDAL MEDICAL CORP. 510(k) NO: K001742(TRADITIONAL) ATTN: CYNTHIA J NOLTE PHONE NO : 919-859-4207 49 PLAIN STREET SE DECISION MADE: 06-OCT-00 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUPER NOVA, ACUBEAM LIGHT FORCE THERAPY, INC. 510(k) NO: K001179(TRADITIONAL) ATTN: KIM PETERSON PHONE NO : 719-749-2974 17725 CLEESE CT. SE DECISION MADE: 27-OCT-00 PAYTON, CO 80831 510(k) STATEMENT DEVICE: ADVANTAGE DRIVE SYSTEM LINVATEC CORP. 510(k) NO: K002523(TRADITIONAL) ATTN: LAURA D SENEFF PHONE NO : 727-399-5234 11311 CONCEPT BOULEVARD SE DECISION MADE: 06-OCT-00 LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LUMALITE CURE LIGHT, MODEL 2100 LUMALITE, INC. 510(k) NO: K002566(TRADITIONAL) ATTN: JOSEPH M FOREHAND PHONE NO : 619-660-5410 2810 VIA ORANGE WAY, STE. B SE DECISION MADE: 19-OCT-00 SPRING VALLEY, CA 91978 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MACROPOREMX MANDIBULAR FIXATION SYSTEM MACROPORE, INC. 510(k) NO: K000696(TRADITIONAL) ATTN: KENNETH K KLEINHENZ PHONE NO : 858-458-0900 6740 TOP GUN ST. SE DECISION MADE: 19-OCT-00 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WHEELCHAIR, MECHANICAL SERIES MODEL 3100 MADA MEDICAL PRODUCTS, INC. 510(k) NO: K002943(TRADITIONAL) ATTN: JEFFERY W ADAM PHONE NO : 201-460-0454 625 WASHINGTON AVE SE DECISION MADE: 23-OCT-00 CARLSTADT, NJ 07072 510(k) STATEMENT DEVICE: AERO-CLICK MAP MEDIZINTECHNIK FUR ARZT UND PA510(k) NO: K993094(TRADITIONAL) ATTN: TORSTEN SCHLICHTHOLZ PHONE NO : 498 989 518723 FRAUNHOFERSTRASSE 16 SE DECISION MADE: 23-OCT-00 MUNCHEN, GERMANY D-82152 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RESPONDER 3000 MARQUETTE HELLIGE GMBH 510(k) NO: K000638(TRADITIONAL) ATTN: KLAUS RUDOLF PHONE NO : 761-454-3379 MUNZINGER STR. 3 SE DECISION MADE: 30-OCT-00 D-79111 FREIBURG, GERMANY 79111 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMBINED PHYSIOLOGICAL MONITORING SYSTEM MARYROSE CUSIMANO, PH.D. & SCOTT Z510(k) NO: K002104(TRADITIONAL) ATTN: MARYROSE CUSIMANO PHONE NO : 954-578-6884 7481 W. OAKLAND PARK BLVD. SE DECISION MADE: 10-OCT-00 # 305 510(k) SUMMARY AVAILABLE FROM FDA FT. LAUDERDALE, FL 33319 DEVICE: MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES MASIMO CORP. 510(k) NO: K002751(SPECIAL) ATTN: JAMES J CRONIN PHONE NO : 949-250-9688 2852 KELVIN AVE. SE DECISION MADE: 05-OCT-00 IRVINE, CA 92614-5826 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE MASIMO CORP. 510(k) NO: K002939(SPECIAL) ATTN: JAMES J CRONIN PHONE NO : 949-250-9688 2852 KELVIN AVE. SE DECISION MADE: 06-OCT-00 IRVINE, CA 92614-5826 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GL MAXXIM MEDICAL 510(k) NO: K002933(ABBREVIATED) ATTN: PALLIE STODDARD PHONE NO : 864-369-7391 308 CHURCH STREET SE DECISION MADE: 19-OCT-00 HONE PATH, SC 29654 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROLITE PULSED LIGHT SYSTEM MEDICAL BIO CARE SWEDEN AB 510(k) NO: K000929(TRADITIONAL) ATTN: CONNIE WHITE HOY PHONE NO : 505-323-2403 9630 TOWNER NE SE DECISION MADE: 17-OCT-00 ALBUQUERQUE, NM 87112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PBN FALLOPIAN TUBE CATHETER SYSTEM MEDICAL DEVICE TECHNOLOGIES, INC. 510(k) NO: K000620(TRADITIONAL) ATTN: KARL SWARTZ PHONE NO : 352-338-0440 3600 S.W. 47TH AVE. SE DECISION MADE: 30-OCT-00 GAINESVILLE, FL 32608 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NIR BILIARY STENT MEDINOL LTD. 510(k) NO: K002130(SPECIAL) ATTN: NASR SALMAN PHONE NO : 972 648 1448 KIRYAT ATIDIM, P.O.B. 58165 SE DECISION MADE: 30-OCT-00 TEL-AVIV, ISRAEL 61581 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MYSONO 201 DIAGNOSTIC ULTRASOUND AND TRANSDUCERS MEDISON AMERICA, INC. 510(k) NO: K003121(TRADITIONAL) ATTN: GARY J ALLSEBROK PHONE NO : 510-276-3559 16303 PANORAMIC WAY SE DECISION MADE: 20-OCT-00 SAN LEANDRO, CA 94578-1116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCESS ALERT GAUGE MEDISYSTEMS CORP. 510(k) NO: K002372(TRADITIONAL) ATTN: FREDRIC SWINDLER PHONE NO : 206-621-6500 1201 3RD AVE. SE DECISION MADE: 25-OCT-00 SEATTLE, WA 98101-3016 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 100 CONTROL UNIT MEDIVANCE, INC. 510(k) NO: K002577(TRADITIONAL) ATTN: ROBERT A KLINE PHONE NO : 303-926-1917 500 S. ARTHUR AVENUE, STE 100 SE DECISION MADE: 26-OCT-00 LOUISVILLE, CO 80027 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDLINE STERILE VINYL EXAM GLOVES, POWDER FREE, YELLOW MEDLINE INDUSTRIES, INC. 510(k) NO: K003091(TRADITIONAL) ATTN: LARA N SIMMONS PHONE NO : 847-949-2639 ONE MEDLINE PL. SE DECISION MADE: 24-OCT-00 MUNDELEIN, IL 60060-4486 510(k) STATEMENT DEVICE: MENICON PROGENT REMOVER MENICON CO. LTD. 510(k) NO: K002140(TRADITIONAL) ATTN: BEVERLEY D VENUTI PHONE NO : 978-658-6888 269A BALLARDVALE STREET SE DECISION MADE: 10-OCT-00 WILMINGTON, MA 01887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDIOBEEPER CB12/12, MODEL CB12/12 MERIDIAN MEDICAL TECHNOLOGIES LTD.510(k) NO: K002310(TRADITIONAL) ATTN: GERARD LYNN PHONE NO : 442 890 222333 207 AIRPORT RD., WEST SE DECISION MADE: 25-OCT-00 BELFAST, IRELAND BT3 9ED 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INQWIRE DIAGNOSTIC GUIDE WIRE MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K002289(SPECIAL) ATTN: CHESTER MCCOY PHONE NO : 801-208-4404 1600 WEST MERIT PKWY. SE DECISION MADE: 04-OCT-00 SOUTH JORDAN, UT 84095 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MDI GLIADIN A TEST MICRO DETECT, INC. 510(k) NO: K002358(TRADITIONAL) ATTN: MEHDI ALEM PHONE NO : 714-832-8234 2852 WALNUT AVE., SUITE H-1 SE DECISION MADE: 19-OCT-00 TUSTIN, CA 92780-7033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MDI GLIADIN G TEST MICRO DETECT, INC. 510(k) NO: K002359(TRADITIONAL) ATTN: MEHDI ALEM PHONE NO : 714-832-8234 2852 WALNUT AVE., SUITE H-1 SE DECISION MADE: 19-OCT-00 TUSTIN, CA 92780-7033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MIDMARK PROCENTER INSTRUMENT DELIVERY SYSTEM MIDMARK CORP. 510(k) NO: K003090(ABBREVIATED) ATTN: MIKE SNYDER PHONE NO : 937-526-8390 OUTE 47 WEST, VISTA DRIVE SE DECISION MADE: 18-OCT-00 VERSAILLES, OH 45380 510(k) STATEMENT DEVICE: ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-4 MISONIX, INC. 510(k) NO: K000927(TRADITIONAL) ATTN: ALBERT F CLANCY JR. PHONE NO : 516-694-9555 1938 NEW HIGHWAY SE DECISION MADE: 10-OCT-00 FARMINGDALE, NY 11735 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MITEK CUFFTACK MITEK PRODUCTS 510(k) NO: K003076(SPECIAL) ATTN: CHRISTINE KUNTZ-NASSIF PHONE NO : 781-251-2794 249 VANDERBILT AVE. SE DECISION MADE: 27-OCT-00 NORWOOD, MA 02062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARRIAZO BARRAQUER II MICROKERATOME MORIA S.A. 510(k) NO: K002191(TRADITIONAL) ATTN: DAVID CONRAD PHONE NO : 331 467 44674 15 RUE GEORGES BESSE SE DECISION MADE: 12-OCT-00 ANTONY, FRANCE 92160 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MWO-202 3D HYDRAULIC COARSE/FINE MICROMANIPULATOR NARISHIGE CO., LTD. 510(k) NO: K002850(TRADITIONAL) ATTN: MITSUKO YONEYAMA PHONE NO : 813 330 88383 27-9 MINAMIKARASUYAMA 4-CHOME SE DECISION MADE: 05-OCT-00 SETAGAY-KU, TOKYO 157-0062, JAPAN 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACHIEVA VENTILATOR Y-ACH+E, ACHIEVA PS VENTILATOR Y-ACHPS+E, ACH NELLCOR PURITAN BENNETT, INC. 510(k) NO: K002686(SPECIAL) ATTN: CHERYL NORTON PHONE NO : 763-694-3500 2800 NORTHWEST BLVD. SE DECISION MADE: 18-OCT-00 MINNEAPOLIS, MN 55441 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEU-ION HEMODIALYIS WATER TREATMENT SYSTEM NEU-ION, INC. 510(k) NO: K001811(TRADITIONAL) ATTN: LEE A HEIKKINEN PHONE NO : 410-944-5200 7200 RUTHERFORD RD. SE DECISION MADE: 25-OCT-00 SUITE 100 510(k) STATEMENT BALTIMORE, MD 21244-2704 DEVICE: NICHOLS ADVANTAGE THYROGLOB NICHOLS INSTITUTE DIAGNOSTICS 510(k) NO: K002888(TRADITIONAL) ATTN: JIMMY WONG PHONE NO : 949-240-5260 33047 CALLE AVIADOR SE DECISION MADE: 20-OCT-00 SAN JUAN CAPISTRANO, CA 92675 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIFE SCOPE P, MODEL BSM-4100 SERIES NIHON KOHDEN AMERICA, INC. 510(k) NO: K001693(TRADITIONAL) ATTN: BONNIE BISHOP PHONE NO : 949-250-3210 2601 CAMPUS DR. SE DECISION MADE: 24-OCT-00 IRVINE, CA 92612-1601 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODEL 2500, PALMSAT HAND HELD PULSE OXIMETER, MODEL 2500 NONIN MEDICAL, INC. 510(k) NO: K002690(SPECIAL) ATTN: RICHARD P BENNETT PHONE NO : 612-553-9968 2605 FERNBROOK LANE, NORTH SE DECISION MADE: 11-OCT-00 MINNEAPOLIS, MN 55447-4755 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANA 2000 NON GAMMA 2 EXTRA HIGH COPPER DENTAL ALLOY NORDISKA DENTAL AB 510(k) NO: K002808(TRADITIONAL) ATTN: RICHARD KIRSCHNER PHONE NO : 425-745-2584 P.O. BOX 435 SE DECISION MADE: 31-OCT-00 LYNWOOD, WA 98046 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANA 3000 SM NON GAMMA 2 MODIFIED SPHERICAL DENTAL ALLOY NORDISKA DENTAL AB 510(k) NO: K002810(TRADITIONAL) ATTN: RICHARD KIRSCHNER PHONE NO : 425-745-2584 P.O. BOX 435 SE DECISION MADE: 31-OCT-00 LYNWOOD, WA 98046 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANA 70 NON GAMMA 2 DISPERSED PHASE DENTAL ALLOY NORDISKA DENTAL AB 510(k) NO: K002811(TRADITIONAL) ATTN: RICHARD KIRSCHNER PHONE NO : 425-745-2584 P.O. BOX 435 SE DECISION MADE: 31-OCT-00 LYNWOOD, WA 98046 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO STAT PROFILE PHOX PLUS ANALYZER NOVA BIOMEDICAL CORP. 510(k) NO: K002613(TRADITIONAL) ATTN: PAUL W MACDONALD PHONE NO : 781-894-0800 200 PROSPECT ST. SE DECISION MADE: 19-OCT-00 WALTHAM, MA 02254-9141 510(k) STATEMENT DEVICE: DISPOSABLE H-PE MICROKERATOME BLADES OASIS 510(k) NO: K001464(TRADITIONAL) ATTN: YVONNE FERNANDEZ PHONE NO : 626-914-2891 514 SOUTH VERMONT AVENUE SE DECISION MADE: 02-OCT-00 GLENDORA, CA 91741 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COLLAGEN WOUND DRESSING OASIS RESEARCH, LLC 510(k) NO: K002443(TRADITIONAL) ATTN: JAMES CHRISTENSEN PHONE NO : 909-305-9857 514 S. VERMONT AVENUE SE DECISION MADE: 18-OCT-00 GLENDORA, CA 91741 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMARTLENS ODC OPHTHALMIC DEVELOPMENT CO. AG 510(k) NO: K002510(TRADITIONAL) ATTN: KEVIN WALLS PHONE NO : 720-962-5412 777 S. WADSWORTH BLVD. SE DECISION MADE: 18-OCT-00 BLDG. 2, SUITE 102 510(k) SUMMARY AVAILABLE FROM FDA LAKEWOOD, CO 80226 DEVICE: OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT OLYMPUS AMERICA, INC. 510(k) NO: K002918(SPECIAL) ATTN: MICHAEL CAMPBELL PHONE NO : 972-556-9697 3131 WEST ROYAL LANE SE DECISION MADE: 25-OCT-00 IRVING, TX 75063-3104 510(k) STATEMENT DEVICE: OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER OLYMPUS AMERICA, INC. 510(k) NO: K002982(SPECIAL) ATTN: MICHAEL CAMPBELL PHONE NO : 972-556-9697 3131 WEST ROYAL LANE SE DECISION MADE: 25-OCT-00 IRVING, TX 75063-3104 510(k) STATEMENT DEVICE: OMNI GRACE LATEX EXAMINATION GLOVE, POWDERED, WITH PROTEIN CLAIM OMNIGRACE (THAILAND) LTD. 510(k) NO: K002922(TRADITIONAL) ATTN: WILLIAM E PATTON PHONE NO : 330-966-8878 7815 VANDERBILT DRIVE NW SE DECISION MADE: 16-OCT-00 NORTH CANTON, OH 44720 510(k) STATEMENT DEVICE: TDK HANDPIECES ORASYSTEMS, LLC 510(k) NO: K000848(TRADITIONAL) ATTN: BERNARD SESSMAN PHONE NO : 973-227-5505 555 PASSAIC AVENUE SE DECISION MADE: 05-OCT-00 WEST CALDWELL, NJ 07006 510(k) STATEMENT DEVICE: BACT/ALERT CSR ORGANON TEKNIKA CORP. 510(k) NO: K003104(TRADITIONAL) ATTN: REBECCA A RIVAS PHONE NO : 919-620-2288 100 AKZO AVE. SE DECISION MADE: 20-OCT-00 DURHAM, NC 27712 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EVANTGARDE/ENDEAVOR POWERED WHEELCHAIR OTTO BOCK ORTHOPEDIC INDUSTRY, INC510(k) NO: K000739(TRADITIONAL) ATTN: WILLIAM JACKSON PHONE NO : 615-773-0002 3000 XENIUM LANE, SUITE N SE DECISION MADE: 24-OCT-00 PLYMOUTH, MN 55441 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOSLEEP OXFORD BIOSIGNALS LIMITED 510(k) NO: K002622(TRADITIONAL) ATTN: PAULINE A HOBDAY PHONE NO : 440 186 5784840 OXFORD SCIENCE PARK SE DECISION MADE: 23-OCT-00 OXFORD, OX4 4 GA, UNITED KINGDOM O510(k) STATEMENT DEVICE: DIGITCARE POWDER FREE COATED EXAMINATION GLOVES WITH PROTEIN CON P.T. HEALTHCARE GLOVINDO 510(k) NO: K000838(TRADITIONAL) ATTN: ELLEN HUTAPEA PHONE NO : 62 61 650015 JL. KOL. YOS SUDARSO K.M. 10 SE DECISION MADE: 23-OCT-00 KAWASAN INDUSRI MEDAN 510(k) STATEMENT MEDAN, INDONESIA 10340 DEVICE: PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, PACE MEDICAL 510(k) NO: K002204(TRADITIONAL) ATTN: ROBERT C MACE PHONE NO : 781-890-5656 391 TOTTEN POND RD. SE DECISION MADE: 18-OCT-00 WALTHAM, MA 02451 510(k) STATEMENT DEVICE: MODEL 4815 ADAPTER PACE MEDICAL 510(k) NO: K002496(TRADITIONAL) ATTN: ROBERT C MACE PHONE NO : 781-890-5656 391 TOTTEN POND RD. SE DECISION MADE: 10-OCT-00 WALTHAM, MA 02451 510(k) STATEMENT DEVICE: MODEL 4810 ANALYZER OUTPUT ADAPTER PACE MEDICAL 510(k) NO: K002497(TRADITIONAL) ATTN: ROBERT C MACE PHONE NO : 781-890-5656 391 TOTTEN POND RD. SE DECISION MADE: 10-OCT-00 WALTHAM, MA 02451 510(k) STATEMENT DEVICE: PHOTON MODULAR WORKSTATION SYSTEM, MODELS Z-12834-"X" & Z-13175- PARADIGM MEDICAL INDUSTRIES, INC. 510(k) NO: K002228(TRADITIONAL) ATTN: TRACY S BEST PHONE NO : 801-977-8970 2355 SOUTH 1070 WEST SE DECISION MADE: 06-OCT-00 SALT LAKE CITY, UT 84119 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEATED HUMIDIFIER PEGASUS RESEARCH CORP. 510(k) NO: K983783(TRADITIONAL) ATTN: E J SMITH PHONE NO : 410-451-0639 1714 SOUTH LYON ST. SE DECISION MADE: 24-OCT-00 SANTA ANA, CA 92705 510(k) STATEMENT DEVICE: PERCLOSE VASCULAR SUTURE DELIVERY DEVICE PERCLOSE, INC. 510(k) NO: K001703(TRADITIONAL) ATTN: DENISE C SUNGLETON PHONE NO : 650-474-3193 400 SAGINAW DRIVE SE DECISION MADE: 03-OCT-00 REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JETCAN HUBER NEEEDLE SET PFM PRODUKTE FUR DIE MEDIZIN AG 510(k) NO: K002471(TRADITIONAL) ATTN: SALVADORE F PALOMARES PHONE NO : 949-463-6146 15 CHEROKEE STREET SE DECISION MADE: 19-OCT-00 TRABUCO CANYON, CA 92679 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1 PHARMACIA & UPJOHN CO. 510(k) NO: K002556(TRADITIONAL) ATTN: TONI D ELLIOTT PHONE NO : 614-834-8629 592 CERESIA COURT SE DECISION MADE: 31-OCT-00 PICKERINGTON,, OH 43147 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TREPCHEK TREPONEMAL ANTIBODY EIA PHOENIX BIOTECH CORP. 510(k) NO: K001552(TRADITIONAL) ATTN: GARY LEHNUS PHONE NO : 908-362-9288 53 CEDAR LAKE ROAD SE DECISION MADE: 19-OCT-00 BLAIRSTOWN, NJ 07825 510(k) STATEMENT DEVICE: 300LC ULTRASOUND IMAGING SYSTEMS, MODEL 300LC PIE MEDICAL 510(k) NO: K002880(TRADITIONAL) ATTN: COLLEEN J HITTLE PHONE NO : 317-849-1916 SE DECISION MADE: 26-OCT-00 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPL CRIMP SYSTEM PIONEER LABORATORIES, INC. 510(k) NO: K002110(TRADITIONAL) ATTN: AMY H MOMMAERTS PHONE NO : 906-226-9909 375 RIVER PARK CIRCLE SE DECISION MADE: 06-OCT-00 MARQUETTE, MI 49855-0627 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TC-PLUS SOLUTION KNEE PLUS ORTHOPEDICS 510(k) NO: K000666(TRADITIONAL) ATTN: HARTMUT LOCH PHONE NO : 858-455-2400 3550 GENERAL ATOMICS CT. SE DECISION MADE: 13-OCT-00 BLDG. 15-100 510(k) SUMMARY AVAILABLE FROM FDA SAN DIEGO, CA 92121-1122 DEVICE: C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET POINTE SCIENTIFIC, INC. 510(k) NO: K002651(TRADITIONAL) ATTN: RON JAMISON PHONE NO : 313-383-7220 1025 JOHN A. PAPALAS DR. SE DECISION MADE: 13-OCT-00 LINCOLN PARK, MI 48146 510(k) STATEMENT DEVICE: RIGID GAS PERMEABLE CONTACT LENS POLYMER TECHNOLOGY 510(k) NO: K002025(TRADITIONAL) ATTN: DEBRA L.B. KETCHUM PHONE NO : 716-338-8638 1400 N GOODMAN STREET SE DECISION MADE: 31-OCT-00 P.O. BOX 30450 510(k) SUMMARY AVAILABLE FROM FDA ROCHESTER, NY 14603-0450 DEVICE: SAFE MINI POLYSTAN A/S 510(k) NO: K980974(TRADITIONAL) ATTN: THOMAS ANDERSEN PHONE NO : 454-465-1566 WALGERHOLM 8 SE DECISION MADE: 13-OCT-00 VAERLOSE, DENMARK DK-3500 510(k) STATEMENT DEVICE: MILLENNIUM EDITION 2000 ACCELERATED ELECTROFORMING SYSTEM PRODUCT DEVELOPMENT INDUSTRIES, IN510(k) NO: K002675(TRADITIONAL) ATTN: RODOLFO A CARBALLO PHONE NO : 520-881-2556 4500 EAST SPEEDWAY BLVD., #50 SE DECISION MADE: 25-OCT-00 TUCSON, AZ 85712 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: X-POSURE SYSTEM VERSION 2 RAD PRONOSCO A/S 510(k) NO: K002500(TRADITIONAL) ATTN: JONATHAN KAHAN PHONE NO : 202-637-5794 555 13TH STREET SE DECISION MADE: 23-OCT-00 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VENTILATOR, CONTINUOUS (RESPIRATOR), MODEL LTV 1000 PULMONETIC SYSTEMS, INC. 510(k) NO: K002881(SPECIAL) ATTN: ROBERT HANKINS PHONE NO : 909-783-2280 930 SOUTH MT. VERNON AVE., SE DECISION MADE: 11-OCT-00 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA COLTON, CA 92324-3928 DEVICE: PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION PURITAN BENNETT CORP. 510(k) NO: K001646(TRADITIONAL) ATTN: MARY E FUNK PHONE NO : 760-603-5957 2200 FARADAY AVE. SE DECISION MADE: 20-OCT-00 CARLSBAD, CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER QUALIGEN, INC. 510(k) NO: K003094(SPECIAL) ATTN: DOROTHY DEINZER PHONE NO : 760-918-9165 2042 CORTE DEL NOGAL SE DECISION MADE: 25-OCT-00 CARLSBAD, CA 92009-1410 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: C.T.M. POWER CHAIR, MODEL HS-5600 R.S. MCQUATE AND ASSOCIATES, INC. 510(k) NO: K002983(TRADITIONAL) ATTN: ROBERT S MCQUATE PHONE NO : 602-788-5651 3636 E. COLUMBINE DR. SE DECISION MADE: 11-OCT-00 PHOENIX, AZ 85032-7372 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRESSURE WIRE SENSOR, MODEL 12003/12303 RADI MEDICAL SYSTEMS AB 510(k) NO: K002962(SPECIAL) ATTN: MATS GRANLUND PHONE NO : 461 816 1000 PALMBLADSGATAN 10 SE DECISION MADE: 04-OCT-00 UPPSALA, SWEDEN S-754 50 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RADIOMED SOURCE RADIOMED CORPORATION 510(k) NO: K001070(TRADITIONAL) ATTN: JOHN SCHWAMB PHONE NO : 978-663-7400 9 LINNELL CIRCLE SE DECISION MADE: 24-OCT-00 BILLERICA, MA 01821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RADIONICS RF DISC CATHETER ELECTRODE SYSTEM RADIONICS, INC. 510(k) NO: K001741(TRADITIONAL) ATTN: KRISTINE CANAVAN PHONE NO : 781-272-1233 22 TERRY AVE. SE DECISION MADE: 23-OCT-00 BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEUROMAP WITH NEURO 100 RADIONICS, INC. 510(k) NO: K002773(TRADITIONAL) ATTN: NANCY C MACDONALD PHONE NO : 781-272-1233 22 TERRY AVE. SE DECISION MADE: 23-OCT-00 BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RANDOX MICROALBUMIN RANDOX LABORATORIES LTD. 510(k) NO: K002674(TRADITIONAL) ATTN: PAULINE ARMSTRONG PHONE NO : 441 849 422413 55 DIAMOND RD. SE DECISION MADE: 05-OCT-00 CRUMLIN, CO. ANTRIM, IRELAND BT29 510(k) STATEMENT DEVICE: REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105) REPROMEDIX CORP 510(k) NO: K001603(TRADITIONAL) ATTN: HAN-SOO KIM PHONE NO : 781-667-8893 86 CUMMINGS PARK, SE DECISION MADE: 05-OCT-00 WOBURN, MA 01801 510(k) STATEMENT DEVICE: REPROBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 107) REPROMEDIX CORP 510(k) NO: K001606(TRADITIONAL) ATTN: HAN-SOO KIM PHONE NO : 781-667-8893 86 CUMMINGS PARK, SE DECISION MADE: 05-OCT-00 WOBURN, MA 01801 510(k) STATEMENT DEVICE: REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104) REPROMEDIX CORP 510(k) NO: K001607(TRADITIONAL) ATTN: HAN-SOO KIM PHONE NO : 781-667-8893 86 CUMMINGS PARK, SE DECISION MADE: 05-OCT-00 WOBURN, MA 01801 510(k) STATEMENT DEVICE: PDT DOSECALCULATOR, MODEL 80000 RETINALABS.COM 510(k) NO: K000418(TRADITIONAL) ATTN: FRANK TIGHE PHONE NO : 800-793-1473 1776 PEACHTREE STREET SE DECISION MADE: 24-OCT-00 200 NORTH 510(k) SUMMARY AVAILABLE FROM FDA ATLANTA, GA 30309 DEVICE: RS NITRILSTAT MEDICAL EXAMINATION GLOVES, POWDER FREE (NON-STERI RIVERSTONE RESOURCES SDN. BHD. 510(k) NO: K003232(TRADITIONAL) ATTN: CHONG CHU MEE PHONE NO : 603 636 8077 LOT 21909, NO.5, LORONG HELAN SE DECISION MADE: 26-OCT-00 HINDIK KEPONG BARU INDUST. EST 510(k) STATEMENT KEPONG BARU, KUALA LUMPUR, MALAYSIA 52100 DEVICE: ELECSYS CA 15-3 TEST SYSTEM ROCHE DIAGNOSTICS CORP. 510(k) NO: K001468(TRADITIONAL) ATTN: PRISCILLA A HAMILL PHONE NO : 317-576-3723 9115 HAGUE RD. SE DECISION MADE: 23-OCT-00 INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECSYS DHEA-S CALSET ROCHE DIAGNOSTICS CORP. 510(k) NO: K002760(TRADITIONAL) ATTN: KAY A TAYLOR PHONE NO : 317-576-3544 9115 HAGUE RD. SE DECISION MADE: 05-OCT-00 INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Q-LUX PLASMA 100 LIGHT CURE UNIT ROLENCE ENTERPRISE CO. LTD. 510(k) NO: K001719(TRADITIONAL) ATTN: STERLING CHENG PHONE NO : 886 346 31999 18-3 LANE 231 PU CHUNG RD. SE DECISION MADE: 10-OCT-00 CHUNGLI 320, CHINA (TAIWAN) 510(k) STATEMENT DEVICE: ASPIJECT SELF-ASPIRATING DENTAL INJECTION SYRINGE RONVIG INSTRUMENTS, LTD. 510(k) NO: K002168(ABBREVIATED) ATTN: ANNETTE RAVN NEILSEN PHONE NO : 45 75 895711 GL.VEJLEVEJ 57-59 SE DECISION MADE: 13-OCT-00 DK-8721 DAUGAARD, DENMARK DK-8721 510(k) STATEMENT DEVICE: PIPER RTEK MEDICAL SYSTEMS, LLC 510(k) NO: K001295(TRADITIONAL) ATTN: ROBERT C JACKSON PHONE NO : 716-249-0984 16 TOBEY VILLAGE OFFICE PARK SE DECISION MADE: 25-OCT-00 PITTSFORD, NY 14534 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDIA FOR GAMETE PREPARATION AND EMBRYO CULTURE SAGE BIOPHARMA 510(k) NO: K002836(SPECIAL) ATTN: GREG HOLLAND PHONE NO : 949-262-0411 3722 AVE. SAUSALITO SE DECISION MADE: 03-OCT-00 IRVINE, CA 92606 510(k) STATEMENT DEVICE: GLIADIN IGA ANTIBODY EIA DETECTION SYSTEM SCIMEDX CORP. 510(k) NO: K002169(TRADITIONAL) ATTN: GARY LEHNUS PHONE NO : 973-625-8822 400 FORD RD. SE DECISION MADE: 19-OCT-00 DENVILLE, NJ 07834 510(k) STATEMENT DEVICE: GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM SCIMEDX CORP. 510(k) NO: K002189(TRADITIONAL) ATTN: GARY L EHNUS PHONE NO : 973-625-8822 400 FORD RD. SE DECISION MADE: 19-OCT-00 DENVILLE, NJ 07834 510(k) STATEMENT DEVICE: MODIFICATION TO IDS5 IMAGE DISPLAY SYSTEM SECTRA-IMTEC AB 510(k) NO: K002936(SPECIAL) ATTN: HERMAN OOSTERWIJK PHONE NO : 940-440-9530 2001 EAST OAKSHORES DRIVE SE DECISION MADE: 17-OCT-00 CROSSROADS, TX 76227 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INVERNESS MEDICAL OVULATION PREDICTOR TEST SELFCARE, INC. 510(k) NO: K002867(SPECIAL) ATTN: CAROL A ADILETTO PHONE NO : 781-647-3900 200 PROSPECT ST. SE DECISION MADE: 12-OCT-00 WALTHAM, MA 02154-3457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOSBABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR SHANGHAI PT PLASTICS ENTERPRISE CO510(k) NO: K002814(TRADITIONAL) ATTN: CHANG T SUN PHONE NO : 862 157 814212 258 YUSHU RD. SE DECISION MADE: 20-OCT-00 CANGQIAO TOWNSHIP 510(k) STATEMENT SHONGJIANG COUNTY, SHANGHAI, CHINA DEVICE: DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR SHANGHAI PT PLASTICS ENTERPRISE CO510(k) NO: K002870(TRADITIONAL) ATTN: PETER WANG PHONE NO : 011 862 157818521 NO. 258, YUSHU ROAD SE DECISION MADE: 16-OCT-00 CANGQIAO TOWNSHIP 510(k) STATEMENT SONGJIANG COUNTY, SHANGHAI, CHINA DEVICE: CATHCOR DESKTOP SIEMENS ELEMA AB 510(k) NO: K002137(TRADITIONAL) ATTN: DAVE SIMARD PHONE NO : 978-097-7737 ELECTROMEDICAL SYSTEMS GROUP SE DECISION MADE: 05-OCT-00 16 ELECTRONICS AVENUE 510(k) SUMMARY AVAILABLE FROM FDA DANVERS, MA 01923 DEVICE: MAGNETOM ALLEGRA SYSTEM SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K002179(TRADITIONAL) ATTN: JAMIE YIEH PHONE NO : 732-321-4625 186 WOOD AVENUE SOUTH SE DECISION MADE: 11-OCT-00 ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOMATOM EMOTION MS SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K003014(TRADITIONAL) ATTN: KATHLEEN RUTHERFORD PHONE NO : 732-231-4779 186 WOOD AVENUE SOUTH SE DECISION MADE: 12-OCT-00 ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K003125(TRADITIONAL) ATTN: JUDI HOFFMAN PHONE NO : 425-557-1229 22010 S.E. 51ST ST. SE DECISION MADE: 20-OCT-00 ISSAQUAH, WA 98029-7002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOMATOM SMILE SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K003152(TRADITIONAL) ATTN: KATHLEEN RUTHERFORD PHONE NO : 732-321-4779 186 WOOD AVENUE SOUTH SE DECISION MADE: 24-OCT-00 ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLYMER COAT, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN SMART GLOVE CORP. SDN BHD 510(k) NO: K002568(TRADITIONAL) ATTN: FOO K PU PHONE NO : 603 391 6100 LOT 6487 BATU 5 3/4 SE DECISION MADE: 03-OCT-00 JALAN KAPAR 510(k) STATEMENT KLANG SELANGOR, MALAYSIA 42100 DEVICE: NEUROTOLOGY DRAPE, MODEL TBD SMITH & NEPHEW ENT. 510(k) NO: K002702(TRADITIONAL) ATTN: GREG SREDIN PHONE NO : 901-373-0200 2925 APPLING RD. SE DECISION MADE: 26-OCT-00 BARTLETT, TN 38133 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMITH & NEPHEW PORPS & TORPS SMITH & NEPHEW ENT. 510(k) NO: K002737(TRADITIONAL) ATTN: ALICIA FARAGE PHONE NO : 901-373-0200 2925 APPLING RD. SE DECISION MADE: 12-OCT-00 BARTLETT, TN 38133 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMITH & NEPHEW PISTONS SMITH & NEPHEW ENT. 510(k) NO: K003214(TRADITIONAL) ATTN: JEFFREY W COBB PHONE NO : 901-373-0200 2925 APPLING RD. SE DECISION MADE: 31-OCT-00 BARTLETT, TN 38133 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MR-III SMITH & NEPHEW, INC. 510(k) NO: K002261(TRADITIONAL) ATTN: DEMETRIOS TSAKONAS PHONE NO : 508-261-3775 160 DASCOMB RD. SE DECISION MADE: 23-OCT-00 ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPEEDLINK TRANSVERSE CONNECTOR SPINAL CONCEPTS, INC. 510(k) NO: K002082(TRADITIONAL) ATTN: DAVID M HOOPER PHONE NO : 512-918-2700 12012 TECHNOLOGY BLVD., #100 SE DECISION MADE: 06-OCT-00 AUSTIN, TX 78727 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASCEND SPINAL FIXATION SYSTEM SPINAL INNOVATIONS, LLC 510(k) NO: K002069(TRADITIONAL) ATTN: KEN RUSSELL PHONE NO : 901-373-8855 7850 STAGE HILLS BLVD. SE DECISION MADE: 05-OCT-00 SUITE 105 510(k) SUMMARY AVAILABLE FROM FDA BARTLETT, TN 38133 DEVICE: STACKHOUSE LENS HOOD, MODEL SA-700/FS STACKHOUSE, INC. 510(k) NO: K003194(SPECIAL) ATTN: TOM GUTIERREZ PHONE NO : 760-778-7255 1100 BIRD CENTER DR. SE DECISION MADE: 26-OCT-00 PALM SPRINGS, CA 92262 510(k) STATEMENT DEVICE: STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTOR STARION INSTRUMENTS 510(k) NO: K002547(TRADITIONAL) ATTN: BRIAN GRIGSBY PHONE NO : 408-741-8773 20665 4TH ST. SE DECISION MADE: 20-OCT-00 SARATOGA, CA 95070 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIMPLICITY DISPOSABLE PEN NEEDLE STERLING MEDIVATIONS, INC. 510(k) NO: K002180(ABBREVIATED) ATTN: JOEL DOUGLAS PHONE NO : 650-949-0407 180 FERNDALE ROAD SOUTH SE DECISION MADE: 13-OCT-00 WAYZATA, MN 55391 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIMPLICITY SOFT INFUSION SET STERLING MEDIVATIONS, INC. 510(k) NO: K002492(ABBREVIATED) ATTN: JOEL DOUGLAS PHONE NO : 650-949-0470 180 FERNDALE ROAD SOUTH SE DECISION MADE: 24-OCT-00 WAYZATA, MN 55391 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRYKER NAVIGATION SYSTEM - ENT MODULE STRYKER CORP. 510(k) NO: K002732(TRADITIONAL) ATTN: NICOLE PETTY PHONE NO : 616-323-7700 4100 EAST MILHAM AVENUE SE DECISION MADE: 02-OCT-00 KALAMAZOO, MI 49001-6197 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JOBSITE ENHANCED MOBILITY CHAIR, MODEL JEM SUITER MEDICAL L.L.C. 510(k) NO: K002876(TRADITIONAL) ATTN: JAMES P SUITER PHONE NO : 800-354-3450 203 WEST 2ND STREET SE DECISION MADE: 11-OCT-00 MC COOK, NE 69001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DURAGARD SODIUM FLUORIDE VARNISH SULTAN DENTAL PRODUCTS, LTD. 510(k) NO: K002581(TRADITIONAL) ATTN: GEORGE WOLFE PHONE NO : 201-894-5500 242 SOUTH DEAN ST. SE DECISION MADE: 20-OCT-00 ENGLEWOOD, NJ 07631 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NATURAL-KNEE II SYSTEM-DURASUL TIBIAL INSERT AND DURASUL ALL-POL SULZER ORTHOPEDICS, INC. 510(k) NO: K002335(TRADITIONAL) ATTN: MITCHELL DHORITY PHONE NO : 512-432-9202 9900 SPECTRUM DR. SE DECISION MADE: 25-OCT-00 AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NATURAL-KNEE II PATELLOFEMORAL JOINT PROSTHESIS SULZER ORTHOPEDICS, INC. 510(k) NO: K002356(TRADITIONAL) ATTN: MITCHELL A DHORITY PHONE NO : 512-432-9900 9900 SPECTRUM DR. SE DECISION MADE: 30-OCT-00 AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRECISION DOSIMETRY ELECTROMETER, MODEL 1010 OR 206 SUN NUCLEAR CORP. 510(k) NO: K002444(TRADITIONAL) ATTN: THOMAS L POWERS PHONE NO : 407-259-6862 425-A PINEDA COURT SE DECISION MADE: 18-OCT-00 MELBOURNE, FL 32940 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RE-ENTRANT CHAMBER, MODEL 1008 OR 44D SUN NUCLEAR CORP. 510(k) NO: K002446(TRADITIONAL) ATTN: THOMAS L POWERS PHONE NO : 407-259-6862 425-A PINEDA COURT SE DECISION MADE: 23-OCT-00 MELBOURNE, FL 32940 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSCAR 2, MODEL 222 SUNTECH MEDICAL INSTRUMENTS, INC. 510(k) NO: K003004(SPECIAL) ATTN: GEORGE MYERS PHONE NO : 201-727-1703 377 ROUTE 17 SE DECISION MADE: 25-OCT-00 HASBROUCK, NJ 07460 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURGI-VISION URETHRAL COIL SURGI-VISION, INC. 510(k) NO: K002345(TRADITIONAL) ATTN: NANCY E TAYLOR PHONE NO : 410-730-8998 9250 RUMSEY RD., SUITE 100 SE DECISION MADE: 11-OCT-00 COLUMBIA, MD 21045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RADIOCAMERAS EXTRACRANIAL SYSTEM SURGICAL NAVIGATION TECHNOLOGIES, 510(k) NO: K000246(TRADITIONAL) ATTN: ROGER WHITE PHONE NO : 303-439-9709 530 COMPTON STREET SE DECISION MADE: 20-OCT-00 BROOMFIELD, CO 80020 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND PRE SURGICAL SPECIALTIES CORP. 510(k) NO: K002849(TRADITIONAL) ATTN: VIKKI M HOFFMAN PHONE NO : 610-404-1000 100 DENNIS DRIVE SE DECISION MADE: 18-OCT-00 READING, PA 19606-3776 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES USS (10.0MM SIDE OPENING SCREWS) SYNTHES 510(k) NO: K003061(SPECIAL) ATTN: JONATHAN GILBERT PHONE NO : 610-647-9700 1690 RUSSELL RD. SE DECISION MADE: 30-OCT-00 P.O. BOX 1766 510(k) SUMMARY AVAILABLE FROM FDA PAOLI, PA 19301-1262 DEVICE: SYNTHES (USA) LOCKING PROXIMAL PLATING (L-PTP) SYSTEM SYNTHES (USA) 510(k) NO: K002361(TRADITIONAL) ATTN: BONNIE J SMITH PHONE NO : 610-647-9700 P.O. BOX 1766 SE DECISION MADE: 31-OCT-00 1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA PAOLI, PA 19301-1222 DEVICE: SYNTHES PROXIMAL HUMERAL NAIL SYNTHES (USA) 510(k) NO: K002729(TRADITIONAL) ATTN: THOMAS M MAGUIRE PHONE NO : 610-647-9700 1690 RUSSELL RD. SE DECISION MADE: 06-OCT-00 PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMALL STATURE USS SYNTHES (USA) 510(k) NO: K994121(TRADITIONAL) ATTN: JONATHAN M GILBERT PHONE NO : 610-647-9700 P.O. BOX 1766 SE DECISION MADE: 17-OCT-00 1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA PAOLI, PA 19301-1222 DEVICE: TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100 TECNO INSTRUMENTS (PVT.) LTD. 510(k) NO: K002257(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 19-OCT-00 GREAT NECK,, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LITEAIRE THAYER MEDICAL CORP. 510(k) NO: K993101(TRADITIONAL) ATTN: DAVID T SLADEK PHONE NO : 520-790-5393 4575 SOUTH PALO VERDE RD., SE DECISION MADE: 26-OCT-00 SUITE 337 510(k) STATEMENT TUCSON, AZ 85714 DEVICE: ANSPACH ANGLED MICRONOSE ATTACHMENT THE ANSPACH EFFORT, INC. 510(k) NO: K002903(TRADITIONAL) ATTN: WILLIAM E ANSPACH III PHONE NO : 561-627-1080 4500 RIVERSIDE DR. SE DECISION MADE: 24-OCT-00 PALM BEACH GARDENS, FL 33410 510(k) STATEMENT DEVICE: SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT THE BINDING SITE, LTD. 510(k) NO: K002560(TRADITIONAL) ATTN: JAY H GELLER PHONE NO : 310-449-1399 WEST TOWER, SUITE 4000 SE DECISION MADE: 26-OCT-00 2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT SANTA MONICA, CA 90404 DEVICE: SHEEP ANTI-HUMAN IGD IMMUNOFIXATION GRADE KIT THE BINDING SITE, LTD. 510(k) NO: K002561(TRADITIONAL) ATTN: JAY H GELLER PHONE NO : 310-449-1399 WEST TOWER, SUITE 4000 SE DECISION MADE: 26-OCT-00 2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT SANTA MONICA, CA 90404 DEVICE: SHEEP ANTI-HUMAN LAMBDA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KI THE BINDING SITE, LTD. 510(k) NO: K002563(TRADITIONAL) ATTN: JAY H GELLER PHONE NO : 310-449-1399 WEST TOWER, SUITE 4000 SE DECISION MADE: 26-OCT-00 2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT SANTA MONICA, CA 90404 DEVICE: SHEEP ANTI-HUMAN KAPPA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT THE BINDING SITE, LTD. 510(k) NO: K002564(TRADITIONAL) ATTN: JAY H GELLER PHONE NO : 310-449-1399 WEST TOWER, SUITE 4000 SE DECISION MADE: 26-OCT-00 2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT SANTA MONICA, CA 90404 DEVICE: REFACTO LABORATORY STANDARD THE GENETICS INSTITUTE 510(k) NO: K002350(TRADITIONAL) ATTN: MARYANN KRANE PHONE NO : 617-665-8737 87 CAMBRIDGE PARK DRIVE SE DECISION MADE: 05-OCT-00 CAMBRIDGE, MA 02140-2387 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPECTRA-VRM Q-SWITCHED ND:YAG LASER SYSTEM, SPECTRA-VRM TISSUE MEDICAL LASERS, INC. 510(k) NO: K000317(TRADITIONAL) ATTN: DWIGHT ZURAWSKI PHONE NO : 505-828-0508 4432 ANAHEIM AVE., N.E. SE DECISION MADE: 27-OCT-00 ALBUQUERQUE, NM 87113 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TORNIER TOTAL ELBOW PROSTHESIS TORNIER S.A. 510(k) NO: K000003(TRADITIONAL) ATTN: DAVID W SCHLERF PHONE NO : 925-356-2640 200 GREGORY LANE SE DECISION MADE: 02-OCT-00 SUITE C-100 510(k) SUMMARY AVAILABLE FROM FDA PLEASANT HILL, CA 94523-3389 DEVICE: 3D ANGIOGRAPHIC IMAGING SYSTEM, MODEL XIDF-100A TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K002424(TRADITIONAL) ATTN: DIANA THORSON PHONE NO : 714-730-5000 2441 MICHELLE DR. SE DECISION MADE: 27-OCT-00 P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA TUSTIN, CA 92781-2068 DEVICE: OPART, MODEL MRT-600 TOSHIBA AMERICA MRI, INC. 510(k) NO: K002522(TRADITIONAL) ATTN: BRUCE CLARK PHONE NO : 650-872-2722 280 UTAH AVE. SE DECISION MADE: 25-OCT-00 SOUTH SAN FRANCISCO, CA 94080 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXCELART WITH PIANISSIMO, MODEL MRT-1501/P3 TOSHIBA AMERICA MRI, INC. 510(k) NO: K002531(TRADITIONAL) ATTN: KEN NEHMER PHONE NO : 650-872-2722 280 UTAH AVE. SE DECISION MADE: 26-OCT-00 SOUTH SAN FRANCISCO, CA 94080 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IRV2000 INDIVIDUAL RECREATIONAL VEHICLE TRAC ABOUT, INC. 510(k) NO: K001835(TRADITIONAL) ATTN: KEVIN WALLS PHONE NO : 720-962-5412 777 S. WADSWORTH BLVD. SE DECISION MADE: 11-OCT-00 BLDG.2. STE. 102 510(k) STATEMENT LAKEWOOD, CO 80226 DEVICE: TUTOPATCH TUTOGEN MEDICAL U.S., INC. 510(k) NO: K991296(TRADITIONAL) ATTN: PJ PARDO PHONE NO : 904-462-2178 13709 PROGRESS BLVD. SE DECISION MADE: 06-OCT-00 BOX 19 510(k) SUMMARY AVAILABLE FROM FDA ALACHUA, FL 32615 DEVICE: AXION PLUS (METHAFILCON A) SOFT (HYDROPHILIC) ASPHERIC CONTRACT UNILENS CORP., USA 510(k) NO: K002408(TRADITIONAL) ATTN: CHARLOTTE B COUECOU PHONE NO : 727-544-2531 10431 72ND ST. NORTH SE DECISION MADE: 17-OCT-00 LARGO, FL 33777 510(k) STATEMENT DEVICE: UNITED #1018-FREEDOM SERIES, UNITED #2018-COMFORT SERIES, UNITED UNITED CHAIR MFG., LLC 510(k) NO: K002318(TRADITIONAL) ATTN: DOUGLAS A HANBY PHONE NO : 614-759-7333 2097 SOUTH HAMILTON ROAD SE DECISION MADE: 11-OCT-00 SUITE 109 510(k) STATEMENT COLUMBUS, OH 43232 DEVICE: SPIRIT ACUPUNCTURE NEEDLE UNITED PACIFIC CO., LTD. 510(k) NO: K003010(TRADITIONAL) ATTN: DANIEL YE HUA PHONE NO : 626-458-8518 219 SOUTH RAYMOND AVE SE DECISION MADE: 19-OCT-00 ALHAMBRA, CA 91801 510(k) STATEMENT DEVICE: VISION 9000 PHASED ARRAY TORSO COIL USA INSTRUMENTS, INC. 510(k) NO: K002482(TRADITIONAL) ATTN: RONY THOMAS PHONE NO : 330-562-1000 1515 DANNER DRIVE SE DECISION MADE: 17-OCT-00 AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWER 5000 GENERAL PURPOSE COIL USA INSTRUMENTS, INC. 510(k) NO: K002483(TRADITIONAL) ATTN: RONY THOMAS PHONE NO : 330-562-1000 1515 DANNER DRIVE SE DECISION MADE: 25-OCT-00 AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PACIFIER THERMOMETER MODELS VT-901F, VT901C VALEO CORP. 510(k) NO: K002562(TRADITIONAL) ATTN: MARIAN HARDING COCHRAN PHONE NO : 954-779-2500 501 SOUTH ANDREWS AVENUE SE DECISION MADE: 13-OCT-00 FT. LAUDERDALE, FL 33301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VISIJET HYDROKERATOME, MODEL 50 VISIJET, INC. 510(k) NO: K991124(TRADITIONAL) ATTN: JUDY F GORDON PHONE NO : 949-854-6314 18732 SAGINAW SE DECISION MADE: 20-OCT-00 IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITREA 2, VERSION 2.1 VITAL IMAGES, INC. 510(k) NO: K002519(TRADITIONAL) ATTN: ROBERT C SAMEC PHONE NO : 612-915-8001 3300 FERNBROOK LANE NORTH SE DECISION MADE: 19-OCT-00 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA PLYMOUTH, MN 55447 DEVICE: AERONEB PORTABLE NEBULIZER VOGUE SHOPS, INC. 510(k) NO: K003022(TRADITIONAL) ATTN: TRACI V.A. EDWARDS PHONE NO : 408-543-2414 6225 POWERS AVE. SE DECISION MADE: 13-OCT-00 JACKSONVILLE, FL 32217 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACTICOAT 7 DRESSING WESTAIM BIOMEDICAL INC. 510(k) NO: K001519(TRADITIONAL) ATTN: STEVE CHARTIER PHONE NO : 603-775-7300 ONE HAMPTON RD., SUITE 302 SE DECISION MADE: 06-OCT-00 EXETER, NH 03833 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DERMAGRIP POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE STE WRP SPECIALTY PRODUCTS SDN. BHD. 510(k) NO: K002975(TRADITIONAL) ATTN: MOHD HAIZAN HUSSEIN PHONE NO : 60 387 069788 LOT11, JL.2,KAWASAN PERUSAHAAN SE DECISION MADE: 24-OCT-00 BANDAR BARU SLAK TINGGI 510(k) SUMMARY AVAILABLE FROM FDA SELANGOR DAURL EHSAN, SEPANG, MALAYSIA 43900 DEVICE: XPS NITRO SYSTEM XOMED, INC. 510(k) NO: K002828(TRADITIONAL) ATTN: MARTIN D SARGENT PHONE NO : 904-279-7586 6743 SOUTHPOINT DR. NORTH SE DECISION MADE: 17-OCT-00 JACKSONVILLE, FL 32216 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TITANIUM MIDDLE EAR PROSTHESES XOMED, INC. 510(k) NO: K002897(TRADITIONAL) ATTN: DAVID TIMLIN PHONE NO : 904-279-7532 6743 SOUTHPOINT DR. NORTH SE DECISION MADE: 11-OCT-00 JACKSONVILLE, FL 32216 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 288 TOTAL WITH SUMMARIES 212 TOTAL WITH STATEMENTS 76
Updated 4/10/2001
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