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510(k)s Final Decisions Rendered for March 2000 |
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DEVICE: ABBOTT GEMSTAR I.V. INFUSION PUMP - 7 THERAPY CONFIGURATION, 6 T ABBOTT LABORATORIES, INC. 510(k) NO: K000821(SPECIAL) ATTN: JILL SACKETT PHONE NO : 847-937-4085 DEPT. 389, AP30 SE DECISION MADE: 24-MAR-00 200 ABBOTT PARK ROAD 510(k) STATEMENT ABBOTT PARK, IL 60064-3537 DEVICE: ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R-2000 ACIST MEDICAL SYSTEMS 510(k) NO: K000013(SPECIAL) ATTN: CARL M BEAURLINE PHONE NO : 612-995-9319 7450 FLYING CLOUDS DR. SE DECISION MADE: 28-MAR-00 SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA EDEN PRAIRIE, MN 55344 DEVICE: PEGASYS ULTRA ADAC LABORATORIES 510(k) NO: K993946(TRADITIONAL) ATTN: JANICE BROWN PHONE NO : 408-321-9100 540 ALDER DR. SE DECISION MADE: 09-MAR-00 MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGEN ADRI 510(k) NO: K000054(TRADITIONAL) ATTN: GEORGE H SCHERR PHONE NO : 708-758-3242 P.O. BOX 134 SE DECISION MADE: 13-MAR-00 PARK FOREST, IL 60466 510(k) STATEMENT DEVICE: OTW MEGALINK SDS BILIARY STENT SYSTEM ADVANCED CARDIOVASCULAR SYSTEMS, I510(k) NO: K000550(SPECIAL) ATTN: SANDRA SUNDELL PHONE NO : 408-845-4278 3200 LAKESIDE DRIVE SE DECISION MADE: 17-MAR-00 SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PATIENT CABLES FOR MONITORING, I.E., ECG, EKG, SPO2, AND BP INTE ADVANTAGE MEDICAL ELECTRONICS, INC510(k) NO: K992524(TRADITIONAL) ATTN: KENNETH E KENDRICKS PHONE NO : 954-345-9800 10630 WILES RD. SE DECISION MADE: 01-MAR-00 CORAL SPRINGS, FL 33076 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AESCULAP BONE WAX AESCULAP, INC. 510(k) NO: K000021(TRADITIONAL) ATTN: STEVE REITZLER PHONE NO : 619-977-1465 13221 MARICOTTE PLACE SE DECISION MADE: 24-MAR-00 SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO HP M2376A DEVICE LINK SYSTEM AGILENT TECHNOLOGIES, INC. 510(k) NO: K000635(SPECIAL) ATTN: MIKE HUDON PHONE NO : 978-659-3173 3000 MINUTEMAN RD. SE DECISION MADE: 20-MAR-00 ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONVERTORS EQUIPMENT DRAPES ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K000417(TRADITIONAL) ATTN: SHARON ROBBINS PHONE NO : 847-785-3311 1500 WAUKEGAN RD. SE DECISION MADE: 17-MAR-00 MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO AIRLIFE HEATED VENTILATOR AND ANESTHESIA BREATHI ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K000697(SPECIAL) ATTN: SHARON ROBBINS PHONE NO : 847-785-3311 1500 WAUKEGAN RD., MPWM SE DECISION MADE: 30-MAR-00 MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACME MEDICAL AESTHETIC ND:YAG LASER ALTUS MEDICAL 510(k) NO: K991798(TRADITIONAL) ATTN: MICHAEL LEVERNIER PHONE NO : 650-552-9700 821 COWAN ROAD SE DECISION MADE: 06-MAR-00 BURLINGAME, CA 94010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMERICAN DENTAL PRODUCTS CARIES-DETECTOR PLUS AMERICAN DENTAL PRODUCTS, INC. 510(k) NO: K994368(TRADITIONAL) ATTN: GEORGE NICOLAE PHONE NO : 630-238-0275 603-B COUNTRY CLUB DR. SE DECISION MADE: 14-MAR-00 BENSENVILLE, IL 60106-1329 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STAPLETAC2 BONE ANCHOR SYSTEM AMERICAN MEDICAL SYSTEMS, INC. 510(k) NO: K000279(SPECIAL) ATTN: SYLVIA L GUBBE PHONE NO : 800-328-3881 10700 BREN RD., WEST SE DECISION MADE: 01-MAR-00 MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEXT STEP POWDER FREE LATEX EXAMINATION GLOVES CONTAINS 50 MCGM ANSELL PERRY INC. 510(k) NO: K000165(TRADITIONAL) ATTN: JAMES R CHATTERTON PHONE NO : 330-833-2811 1875 HARSH AVENUE, S.E. SE DECISION MADE: 10-MAR-00 MASSILLON, OH 44646-7199 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER APPLE MEDICAL CORP. 510(k) NO: K000026(TRADITIONAL) ATTN: JOHN PULFORD PHONE NO : 800-255-2926 28 LORD RD., UNIT 135 SE DECISION MADE: 31-MAR-00 MARLBORO, MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS C ARROW INTL., INC. 510(k) NO: K993691(TRADITIONAL) ATTN: THOMAS D NICKEL PHONE NO : 610-478-3137 2400 BERNVILLE ROAD SE DECISION MADE: 08-MAR-00 READING, PA 19605 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWI ARTHROCARE CORP. 510(k) NO: K000511(SPECIAL) ATTN: BRUCE PROTHRO PHONE NO : 408-736-0224 595 NORTH PASTORIA AVE. SE DECISION MADE: 13-MAR-00 SUNNYVALE, CA 94086 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VISAGE COSMETIC SURGERY, MODEL V5000 ARTHROCARE CORP. 510(k) NO: K992180(TRADITIONAL) ATTN: BRUCE PROTHRO PHONE NO : 408-736-0224 595 NORTH PASTORIA AVE. SE DECISION MADE: 20-MAR-00 SUNNYVALE, CA 94086 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODULAP ATC TECHNOLOGIES, INC. 510(k) NO: K994319(TRADITIONAL) ATTN: MARIAN HARDING COCHRAN PHONE NO : 954-929-4317 1034 LINCOLN STREET SE DECISION MADE: 20-MAR-00 HOLLYWOOD, FL 33019 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HDI 1500/SA 8800 ULTRASOUND SYSTEM WITH MULTIPLANE TRANSESOPHAGE ATL ULTRASOUND, INC. 510(k) NO: K994373(TRADITIONAL) ATTN: TERRANCE J SWEEENEY PHONE NO : 425-487-7602 P.O. BOX 3003 SE DECISION MADE: 24-MAR-00 BOTHELL, WA 98041-3003 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVANTA SUPER SOFT GRAFT ATRIUM MEDICAL CORP. 510(k) NO: K000499(SPECIAL) ATTN: KAREN HALL PHONE NO : 603-880-1433 5 WENTWORTH DR. SE DECISION MADE: 01-MAR-00 HUDSON, NH 03051 510(k) STATEMENT DEVICE: ADVANTA SUPER SOFT GRAFT ATRIUM MEDICAL CORP. 510(k) NO: K000504(SPECIAL) ATTN: KAREN HALL PHONE NO : 603-880-1433 5 WENTWORTH DR. SE DECISION MADE: 01-MAR-00 HUDSON, NH 03051 510(k) STATEMENT DEVICE: AVL OPTI R ANALYZER AVL SCIENTIFIC CORP. 510(k) NO: K000103(TRADITIONAL) ATTN: RANDY BYRD PHONE NO : 770-576-5000 235 HEMBREE PARK DR. SE DECISION MADE: 20-MAR-00 ROSWELL, GA 30076 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRASOUND SCANNER TYPE 2102 B & K MEDICAL A/S 510(k) NO: K000567(SPECIAL) ATTN: VILLY BRAENDER PHONE NO : 011 454 5970100 SANDTOFTEN 9 SE DECISION MADE: 09-MAR-00 GENTOFTE, DENMARK DK-2820 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HORIZON LIGHT B. BRAUN MEDICAL, INC. 510(k) NO: K994375(TRADITIONAL) ATTN: GARY GULYAS PHONE NO : 972-245-2243 1601 WALLACE DR., SUITE 150 SE DECISION MADE: 08-MAR-00 CARROLLTON, TX 75006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CELSITE IMPLANTABLE PORT WITH VALVED CATHETER B. BRAUN OF AMERICA, INC. 510(k) NO: K993024(TRADITIONAL) ATTN: MARK S ALSBERGE PHONE NO : 610-266-0500 901 MARCON BLVD. SE DECISION MADE: 13-MAR-00 ALLENTOWN, PA 18103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BALLARD MEDICAL PRODUCTS EPIDURAL AND SPINAL NEEDLES BALLARD MEDICAL PRODUCTS 510(k) NO: K000495(TRADITIONAL) ATTN: E. MARTIN CHAMBERLAIN PHONE NO : 801-572-6800 12050 LONE PEAK PKWY. SE DECISION MADE: 28-MAR-00 DRAPER, UT 84020 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BARCOMED 5MP1H BARCO NV 510(k) NO: K000014(TRADITIONAL) ATTN: FRANK FERGUSON PHONE NO : 858-587-1147 P.O. BOX 12038 SE DECISION MADE: 14-MAR-00 LA JOLLA, CA 92039-2038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BARCOMED 5MP2 BARCO NV 510(k) NO: K000016(TRADITIONAL) ATTN: FRANK FERGUSON PHONE NO : 858-587-1147 P.O. BOX 12038 SE DECISION MADE: 14-MAR-00 LA JOLLA, CA 92039-2038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MFCD 118 BARCO NV 510(k) NO: K000291(TRADITIONAL) ATTN: FRANK FERGUSON PHONE NO : 858-587-1147 P.O. BOX 12038 SE DECISION MADE: 27-MAR-00 LA JOLLA, CA 92039-2038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BARCO MWD 321 PLUS MEDICAL WORKSTATION DISPLAY BARCO NV 510(k) NO: K000292(TRADITIONAL) ATTN: FRANK FERGUSON PHONE NO : 858-587-1147 P.O. BOX 12038 SE DECISION MADE: 29-MAR-00 LA JOLLA, CA 92039-2038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BARCO MGD 221 2 MEGAPIXEL DIAGNOSTIC DISPLAY BARCO NV 510(k) NO: K000293(TRADITIONAL) ATTN: FRANK FERGUSON PHONE NO : 858-587-1147 P.O. BOX 12038 SE DECISION MADE: 29-MAR-00 LA JOLLA, CA 92039-2038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MFCD 120 BARCO NV 510(k) NO: K000294(TRADITIONAL) ATTN: FRANK FERGUSON PHONE NO : 858-587-1147 P.O. BOX 12038 SE DECISION MADE: 27-MAR-00 LA JOLLA, CA 92039-2038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BAUSCH & LOMB 2-WEEK (HILAFILCON B) VISIBILITY TINTED CONTACT LE BAUSCH & LOMB, INC. 510(k) NO: K994125(TRADITIONAL) ATTN: GLENN A DAVIES PHONE NO : 716-338-8215 1400 NORTH GOODMAN STREET SE DECISION MADE: 03-MAR-00 ROCHESTER, NY 14692-0450 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LUER ACCESS UNIVERSAL VIAL ADAPTER BAXTER HEALTHCARE CORP. 510(k) NO: K000657(TRADITIONAL) ATTN: MARY ELLEN SNYDER PHONE NO : 847-270-4644 RT. 120 AND WILSON ROAD SE DECISION MADE: 08-MAR-00 ROUND LAKE, IL 60073-0490 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD PREEFILE NORMAL SALINE FLUSH SYRINGE FLUSH SYRINGE BD/PREEFIL 510(k) NO: K982558(TRADITIONAL) ATTN: GREG MORGAN PHONE NO : 201-847-4344 1 BECTON DR. MC 226 SE DECISION MADE: 08-MAR-00 FRANKLIN LAKES, NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ISOSEED PD-103 BEBIG ISOTOPENTECHNIK GMBH 510(k) NO: K993552(TRADITIONAL) ATTN: SVEN LANGER PHONE NO : 493 094 70840 X 76 ROBERT-ROSSLE/STR.10 SE DECISION MADE: 31-MAR-00 BERLIN-BUCH, GERMANY 13125 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER BECKMAN COULTER, INC. 510(k) NO: K000716(SPECIAL) ATTN: ANGELA M BYLAND PHONE NO : 612-368-1615 1000 LAKE HAZELTINE DR. SE DECISION MADE: 20-MAR-00 CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCESS OSTASE IMMUNOENZYMETRIC ASSAY BECKMAN COULTER, INC. 510(k) NO: K994278(TRADITIONAL) ATTN: JILL KULL PHONE NO : 858-621-4584 7330 CARROLL ROAD SE DECISION MADE: 28-MAR-00 SAD DIEGO, CA 92196-9006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FRESCO PHOSPHENE TONOMETER AND OR PHOSPHENE TONOMETER AND OR FPT BERNARD B. FRESCO 510(k) NO: K991840(TRADITIONAL) ATTN: BERNARD B FRESCO PHONE NO : 416 922 2707 40 SAINT CLAIR AVE EAST 303 SE DECISION MADE: 20-MAR-00 TORONTO, ONTARIO, CANADA M4T 1M9 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NITRI-CARE NITRILE POWDER-FREE STERILE MEDICAL EXAMINATION GLOVE BEST MFG. CO. 510(k) NO: K993805(TRADITIONAL) ATTN: DAVID C YOUNG PHONE NO : 706-862-2302 579 EDISON STREET SE DECISION MADE: 10-MAR-00 MENLO, GA 30731 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYLASINE BIOMATRIX, INC. 510(k) NO: K993362(TRADITIONAL) ATTN: MARIO J RERES PHONE NO : 201-945-9550 65 RAILROAD AVE. SE DECISION MADE: 13-MAR-00 RIDGEFIELD, NJ 07657 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYLASHIELD CL BIOMATRIX, INC. 510(k) NO: K994170(TRADITIONAL) ATTN: NADINE M QASHU PHONE NO : 201-945-9550 65 RAILROAD AVE. SE DECISION MADE: 02-MAR-00 RIDGEFIELD, NJ 07657 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MALLORY/HEAD LATERALIZED PRESS-FIT FEMORAL BIOMET, INC. 510(k) NO: K000538(SPECIAL) ATTN: DALENE T BINKLEY PHONE NO : 219-372-1612 AIRPORT INDUSTRIAL PARK SE DECISION MADE: 15-MAR-00 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46580 DEVICE: SMARTWEDGE ACL, MODELS 430623, 430628, 430723, 430728, 430823, 4 BIONX IMPLANTS, LTD. 510(k) NO: K000616(SPECIAL) ATTN: TUIJA ANNALA PHONE NO : 358 331 65600 HERMIANKATU 6-8 L SE DECISION MADE: 23-MAR-00 TAMPERE, FINLAND FIN-33720 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRIAGE BNP CALIBRATION VERIFICATION CONTROLS BIOSITE DIAGNOSTICS 510(k) NO: K000231(TRADITIONAL) ATTN: JOHN F BRUNI PHONE NO : 619-455-4808 11030 ROSELLE ST. SE DECISION MADE: 02-MAR-00 SAN DIEGO, CA 92121 510(k) STATEMENT DEVICE: BLADEWORKS MICROKERATOME BLADE BLADE WORKS INC. 510(k) NO: K993225(TRADITIONAL) ATTN: GARY S MOCNIK PHONE NO : 949-363-2953 107 SOUTH COVINGTON STREET SE DECISION MADE: 20-MAR-00 HILLSBORO, TX 76445 510(k) STATEMENT DEVICE: BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT BODYSTAT LTD. 510(k) NO: K994242(TRADITIONAL) ATTN: I. J MEEUWSEN PHONE NO : 440 162 4629571 PO BOX 50 SE DECISION MADE: 15-MAR-00 DOUGLAS ISLE OF MAN IM99 IDDQ 510(k) STATEMENT BRITISH ISLES, BRAZIL DEVICE: ART-M3 25K, MODEL M3-1-ART2-A1; ART-M3 30K, MODEL M3-1-ART3-A1 BONART CO. LTD. 510(k) NO: K994203(TRADITIONAL) ATTN: BANKSON TSAI PHONE NO : 886 222 983980 RM. 405, NO.3 WUCHUAN 1ST ROAD SE DECISION MADE: 06-MAR-00 HSINCHUANG, TAIPEI, CHINA (TAIWAN)510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ART-P3, MODEL P3-1-ART-A1 BONART CO. LTD. 510(k) NO: K994299(TRADITIONAL) ATTN: BANKSON TSAI PHONE NO : 886 222 983980 RM. 405, NO.3 WUCHUAN 1ST ROAD SE DECISION MADE: 06-MAR-00 HSINCHUANG, TAIPEI, CHINA (TAIWAN)510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; IN BOSTON SCIENTIFIC CORP. 510(k) NO: K000397(SPECIAL) ATTN: ABBY LIPMAN PHONE NO : 508-650-8249 ONE BOSTON SCIENTIFIC PLACE SE DECISION MADE: 07-MAR-00 NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SEMI COMPLIANT (SC) 35 BALLOON DILATATION CATHETER BOSTON SCIENTIFIC CORP. 510(k) NO: K993303(TRADITIONAL) ATTN: TERRY A MCGOVERN PHONE NO : 508-652-5439 ONE BOSTON SCIENTIFIC PLACE SE DECISION MADE: 23-MAR-00 NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BOSTON SCIENTIFIC/TARGET SENTRY OCCLUSION BALLOON CATHETER BOSTON SCIENTIFIC, TARGET 510(k) NO: K993292(TRADITIONAL) ATTN: GOWAN LEE PHONE NO : 800-662-2415 47900 BAYSIDE PARKWAY SE DECISION MADE: 23-MAR-00 FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BRAHMS DIAGNOSTICA LUMITEST ANTI-TG BRAHMS DIAGNOSTICA, LLC 510(k) NO: K000286(TRADITIONAL) ATTN: H. LEE HERRON PHONE NO : 770-449-7738 29 SOUTH PEACHTREE STREET SE DECISION MADE: 17-MAR-00 NORCROSS, GA 30071 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BRAHMS DIAGNOSTICA LUMITEST ANTI-TPO BRAHMS DIAGNOSTICA, LLC 510(k) NO: K000287(TRADITIONAL) ATTN: H. LEE HERRON PHONE NO : 770-449-7738 29 SOUTH PEACHTREE STREET SE DECISION MADE: 17-MAR-00 NORCROSS, GA 30071 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEMOTHERM COLORECTAL STENT C.R. BARD, INC. 510(k) NO: K990504(TRADITIONAL) ATTN: MARION GORDON PHONE NO : 978-262-4867 129 CONCORD RD., BLDG. #3 SE DECISION MADE: 16-MAR-00 BILLERICA, MA 01821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BARD ENDOSCOPIC SUTURING SYSTEM C.R. BARD, INC. 510(k) NO: K994290(TRADITIONAL) ATTN: BETH A ZIS PHONE NO : 978-262-4866 129 CONCORD RD., BLDG. 3 SE DECISION MADE: 20-MAR-00 BILLERICA, MA 01821-7031 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TOOTHBRUSH WASH CAL HUECH INC. 510(k) NO: K994144(TRADITIONAL) ATTN: CHERYL A LITTLE PHONE NO : 912-953-5771 105 SETTLERS TRAIL SE DECISION MADE: 02-MAR-00 WARNER ROBINS, GA 31088 510(k) STATEMENT DEVICE: CARDIAC PATHWAYS REFERENCE CATHETER AND REFERENCE CATHETER WITH CARDIAC PATHWAYS CORP. 510(k) NO: K992912(TRADITIONAL) ATTN: DEBRA S ECHT PHONE NO : 408-737-0505 995 BENECIA AVE. SE DECISION MADE: 08-MAR-00 SUNNYVALE, CA 94086 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDIOTRON EKG MULTI-PHASE INFORMATION ANALYSIS SYSTEM, MODELS 3 CARDIOTRON, LLC 510(k) NO: K992703(TRADITIONAL) ATTN: WILLIAM D HARE PHONE NO : 202-783-5070 601 13TH STREET, N.W. SE DECISION MADE: 21-MAR-00 SUITE 901 SOUTH 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20005 DEVICE: (TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT CARDIOVASCULAR DIAGNOSTICS, INC. 510(k) NO: K994194(TRADITIONAL) ATTN: PETER SCOTT PHONE NO : 800-849-7070 5301 DEPARTURE DR. SE DECISION MADE: 28-MAR-00 RALEIGH, NC 27616 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IOLMASTER CARL ZEISS, INC. 510(k) NO: K993357(TRADITIONAL) ATTN: SCOTT A MARGOLIN PHONE NO : 914-681-7880 ONE ZEISS DR. SE DECISION MADE: 20-MAR-00 THORNWOOD, NY 10594 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OOCYTE ASPIRATION NEEDLE CASMED UK 510(k) NO: K991271(TRADITIONAL) ATTN: DEBORAH CASTLE PHONE NO : 017 373 79898 39 NORK WAY BANSTEAD SE DECISION MADE: 08-MAR-00 SURREY, UNITED KINGDOM SM7 1PB 510(k) STATEMENT DEVICE: CBYON SURGICAL OPERATING SYSTEM (SOS) CBYON, INC. 510(k) NO: K000171(TRADITIONAL) ATTN: RORY RANDALL PHONE NO : 650-842-1800 2275 E. BAYSHORE RD SE DECISION MADE: 13-MAR-00 SUITE 101 510(k) SUMMARY AVAILABLE FROM FDA PALO ALTO, CA 94303 DEVICE: COBE HVR 2200 HARDSHELL VENOUS RESERVOIR, FILTERED COBE CARDIOVASCULAR, INC. 510(k) NO: K994389(TRADITIONAL) ATTN: LYNNE LEONARD PHONE NO : 303-467-6586 14401 WEST 65TH WAY SE DECISION MADE: 27-MAR-00 ARVADA, CO 80004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUTOSTAT II RHEUMATOID FACTOR IGA ELISA COGENT DIAGNOTICS LTD. 510(k) NO: K993557(TRADITIONAL) ATTN: DANIELLE M KNIGHT PHONE NO : 714-933-3000 PENTLANDS SCIENCE PARK SE DECISION MADE: 03-MAR-00 BUSH LOAN 510(k) STATEMENT EDINBURGH, UNITED KINGDOM EH26 OPL DEVICE: COHERENT LASERLINK Z-1000 SLIT LAMP LASER DELIVERY ADAPTER COHERENT, INC. 510(k) NO: K000498(SPECIAL) ATTN: EDWARD C YU PHONE NO : 408-764-3912 2400 CONDENSA ST. SE DECISION MADE: 13-MAR-00 SANTA CLARA, CA 95051-0901 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PARAPOST FIBER WHITE COLTENE/WHALEDENT INC. 510(k) NO: K000311(TRADITIONAL) ATTN: H.J. VOGELSTEIN PHONE NO : 201-512-8000 750 CORPORATE DR. SE DECISION MADE: 14-MAR-00 MAHWAH, NJ 07430-2009 510(k) STATEMENT DEVICE: COMPUMEDICS E-SERIES EEG SYSTEM COMPUMEDICS NEURO SCIENCE PTY LTD.510(k) NO: K000068(TRADITIONAL) ATTN: CONSTANCE G BUNDY PHONE NO : 612-574-1976 6470 RIVERVIEW TERRACE SE DECISION MADE: 13-MAR-00 MINNEAPOLIS, MN 55432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OVUM PICK-UP NEEDLES WITH AQ COATING, ASPIRATION NEEDLES WITH AQ COOK UROLOGICAL, INC. 510(k) NO: K994417(TRADITIONAL) ATTN: DEBBIE SCHMITT PHONE NO : 812-829-4891 1100 WEST MORGAN ST. SE DECISION MADE: 01-MAR-00 P.O. BOX 227 510(k) SUMMARY AVAILABLE FROM FDA SPENCER, IN 47460 DEVICE: FREQUENCY 55, FREQUENCY 55 ASPHERIC, ENCORE, ENCORE TORIC, ONEVI COOPERVISION, INC. 510(k) NO: K000384(SPECIAL) ATTN: BONNIE TSYMBAL PHONE NO : 716-264-3210 711 NORTH RD. SE DECISION MADE: 06-MAR-00 SCOTTSVILLE, NY 14546 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORDIS MEDIUM PALMAZ TRANSHEPATIC BILIARY STENT & DELIVERY CORDIS CORP. 510(k) NO: K000564(SPECIAL) ATTN: KAREN WILK PHONE NO : 908-412-7257 7 POWDERHORN DRIVE SE DECISION MADE: 23-MAR-00 WARREN, NJ 07059 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENVOY AND VISTA BRITE TIP CORDIS CORP. 510(k) NO: K000715(SPECIAL) ATTN: DENNIS S GRIFFIN PHONE NO : 305-824-5283 14201 N.W. 60TH AVE. SE DECISION MADE: 31-MAR-00 MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROD TO ROD CROSS BRACES CORIN LTD. 510(k) NO: K000634(SPECIAL) ATTN: MEL LONGHURST PHONE NO : 011 441 28565966 THE CORINIUM CENTER SE DECISION MADE: 10-MAR-00 CIRENCESTER, UNITED KINGDOM GL71YJ510(k) STATEMENT DEVICE: THE LIGAMENT ANCHOR SOFT SCREW CORIN U.S.A. 510(k) NO: K994152(TRADITIONAL) ATTN: CRAIG CORRANCE PHONE NO : 813-979-0042 10500 UNIVERSITY CENTER DR., SE DECISION MADE: 06-MAR-00 SUITE 190 510(k) SUMMARY AVAILABLE FROM FDA TAMPA, FL 33612 DEVICE: CORTEK CYSTOSCOPE CORTEK ENDOSCOPY, INC. 510(k) NO: K000197(TRADITIONAL) ATTN: CORNEL M TOPALA PHONE NO : 847-963-8487 501 W. COLFAX, SUITE B SE DECISION MADE: 03-MAR-00 PALATINE, IL 60067 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORTEK URETHEROSCOPE CORTEK ENDOSCOPY, INC. 510(k) NO: K000200(TRADITIONAL) ATTN: CORNEL M TOPALA PHONE NO : 847-963-8487 501 W. COLFAX, SUITE B SE DECISION MADE: 03-MAR-00 PALATINE, IL 60067 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORTEK LAPAROSCOPES CORTEK ENDOSCOPY, INC. 510(k) NO: K000202(TRADITIONAL) ATTN: CORNEL M TOPALA PHONE NO : 847-963-8487 501 W. COLFAX, SUITE B SE DECISION MADE: 31-MAR-00 PALATINE, IL 60067 510(k) STATEMENT DEVICE: MPT 24 AND VITAL VIEW 24 CRITICARE SYSTEMS, INC. 510(k) NO: K000276(SPECIAL) ATTN: ALEX KAPLAN PHONE NO : 262-798-8282 20925 CROSSROADS CIRCLE SE DECISION MADE: 01-MAR-00 WAUKESHA, WI 53186 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CYNOSURE PHOTOGENICA VLS-STAR CYNOSURE, INC. 510(k) NO: K000490(SPECIAL) ATTN: GEORGE CHO PHONE NO : 978-256-4200 10 ELIZABETH DR. SE DECISION MADE: 13-MAR-00 CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIMENSION SPECIAL PROTEIN CALIBRATOR DADE BEHRING, INC. 510(k) NO: K994291(TRADITIONAL) ATTN: RICHARD M VAUGHT PHONE NO : 302-631-6567 P.O. BOX 6101 SE DECISION MADE: 01-MAR-00 ROUTE 896, GLASGOW BLDG. 500 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714-6101 DEVICE: DIMENSION C4 FLEX REAGENT CARTRIDGE DADE BEHRING, INC. 510(k) NO: K994293(TRADITIONAL) ATTN: RICHARD M VAUGHT PHONE NO : 302-631-6567 P.O. BOX 6101 SE DECISION MADE: 01-MAR-00 ROUTE 896, GLASGOW BLDG. 500 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714-6101 DEVICE: DIMENSION C3 FLEX REAGENT CARTRIDGE DADE BEHRING, INC. 510(k) NO: K994296(TRADITIONAL) ATTN: RICHARD M VAUGHT PHONE NO : 302-631-6567 P.O. BOX 6101 SE DECISION MADE: 01-MAR-00 GLASGOW BLDG. 500 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714-6101 DEVICE: FIBRINOGEN CALIBRATOR KIT DADE BEHRING, INC. 510(k) NO: K994341(TRADITIONAL) ATTN: REBECCA S AYASH PHONE NO : 302-631-6276 P.O. BOX 6101 SE DECISION MADE: 03-MAR-00 GLASGOW BLDG. 500 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714-6101 DEVICE: DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR DAKO CORP. 510(k) NO: K993957(TRADITIONAL) ATTN: GRETCHEN M MURRAY PHONE NO : 805-566-6655 6392 VIA REAL SE DECISION MADE: 03-MAR-00 CARPINTERIA, CA 93013 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DATASCOPE'S 8FR. POLYMIDE 25CC,34CC AND 40CC IAB AND ACCESSORIES DATASCOPE CORP. 510(k) NO: K994157(TRADITIONAL) ATTN: WHITNEY TORNING PHONE NO : 973-244-6136 15 LAW DR. SE DECISION MADE: 13-MAR-00 FAIRFIELD, NJ 07004-3206 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER DATEX-OHMEDA, INC. 510(k) NO: K993512(SPECIAL) ATTN: DALE THANIG PHONE NO : 303-666-7001 1315 WEST CENTURY DR. SE DECISION MADE: 31-MAR-00 LOUISVILLE, CO 80027 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DATEX-OHMEDA TONOMETRY MODULE M-TONO DATEX-OHMEDA, INC. 510(k) NO: K993656(TRADITIONAL) ATTN: JOEL C KENT PHONE NO : 800-635-6099 3 HIGHWOOD DR. SE DECISION MADE: 15-MAR-00 TEWKSBURY, MA 01876 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUPRO PROPHYLAXIS PASTE WITH FLUORIDE AND TRICLOSAN DENTSPLY INTL. 510(k) NO: K000169(TRADITIONAL) ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511 570 WEST COLLEGE AVE. SE DECISION MADE: 24-MAR-00 YORK, PA 17405 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHORALIX 9200, ORTHORALIX 9200 PLUS, ORTHORALIX 9200 CEPH, ORT DENTSPLY INTL. 510(k) NO: K994285(TRADITIONAL) ATTN: WILLIAM T COUSINS PHONE NO : 847-640-4924 901 WEST OAKTON ST. SE DECISION MADE: 14-MAR-00 DES PLAINES, IL 60018-1884 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PINNACLE ACETABULAR SYSTEM DEPUY ORTHOPAEDICS, INC. 510(k) NO: K000306(SPECIAL) ATTN: LYNNETTE WHITAKER PHONE NO : 219-371-4903 700 ORTHOPAEDIC DR. SE DECISION MADE: 23-MAR-00 WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLOBAL ADVANTAGE EXTENDED HUMERAL HEAD DEPUY ORTHOPAEDICS, INC. 510(k) NO: K000575(TRADITIONAL) ATTN: MARCIA J ARENTZ PHONE NO : 219-371-4944 700 ORTHOPAEDIC DR. SE DECISION MADE: 10-MAR-00 WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REFLEX TREATMENT SYSTEM DESCHUTES MEDICAL PRODUCTS, INC. 510(k) NO: K994079(TRADITIONAL) ATTN: DENISE BESTWICK PHONE NO : 541-385-0350 1011 S.W. EMKAY DR., SUITE 104 SE DECISION MADE: 01-MAR-00 BEND, OR 97702 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMMULITE VALPROIC ACID, IMMULITE 2000 VALPROIC ACID, CATALOG # L DIAGNOSTIC PRODUCTS CORP. 510(k) NO: K000005(TRADITIONAL) ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200 5700 WEST 96TH ST. SE DECISION MADE: 03-MAR-00 LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5 DIAGNOSTIC PRODUCTS CORP. 510(k)NO:K000012(TRADITIONAL) ATTN: EDWARD M LEVINE PHONE NO : 310-645-8200 5700 WEST 96TH ST. SE DECISION MADE: 03-MAR-00 LOS ANGELES, CA 90045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UCLA/UNIVERSAL ABUTMENT DIAMODENT, INC. 510(k) NO: K993129(TRADITIONAL) ATTN: JEFF RASSOLI PHONE NO : 714-637-7483 695 SOUTH MORNINGSTAR DRIVE SE DECISION MADE: 28-MAR-00 ANAHEIM, CA 92808 510(k) STATEMENT DEVICE: NARKOMED 6000 DRAEGER MEDICAL, INC. 510(k) NO: K993826(TRADITIONAL) ATTN: GALE E WINARSKY PHONE NO : 215-721-5400 3135 QUARRY RD. SE DECISION MADE: 23-MAR-00 TELFORD, PA 18969 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1 E. BENSON HOOD LAB, INC. 510(k) NO: K000154(TRADITIONAL) ATTN: ANTHONY M SACCHETTI PHONE NO : 781-826-7573 575 WASHINGTON ST. SE DECISION MADE: 29-MAR-00 PEMBROKE, MA 02359 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM EBI, L.P. 510(k) NO: K000513(SPECIAL) ATTN: JON CAPAROTTA PHONE NO : 973-299-9022 100 INTERPACE PKWY. SE DECISION MADE: 07-MAR-00 PARSIPPANY, NJ 07054-1079 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CODE AC: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE-A ELGEMS, LTD. 510(k) NO: K994167(TRADITIONAL) ATTN: DAN LAOR PHONE NO : 972 485 63660 P.O. BOX 170 SE DECISION MADE: 07-MAR-00 TIRAT HACARMEL, ISRAEL 30200 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ISOBAR SPINAL SYSTEM ENCORE ORTHOPEDICS, INC. 510(k) NO: K000425(SPECIAL) ATTN: DEBBIE DE LOS SANTOS PHONE NO : 512-834-6237 9800 METRIC BLVD. SE DECISION MADE: 07-MAR-00 AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERICHEK TOTAL CHLORINE REAGENT STRIPS ENVIRONMENTAL TEST SYSTEMS, INC. 510(k) NO: K994226(TRADITIONAL) ATTN: DAVID A MORRIS PHONE NO : 219-262-2060 23575 COUNTY RD., #106 SE DECISION MADE: 22-MAR-00 ELKHART, IN 46514 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MULTICOMPATIBLE ENVITEC FINGER CLIP SENSOR, MULTICOMPATIBLE ENVI ENVITEC-WISMAR GMBH 510(k) NO: K992215(TRADITIONAL) ATTN: STEPHEN H GORSKI PHONE NO : 414-594-2114 N8259 COTTAGE DRIVE SE DECISION MADE: 29-MAR-00 FOND DU LAC, WI 54937 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EP MEDSYSTEMS, EP-WORKMATE EP MEDSYSTEMS, INC. 510(k) NO: K994011(SPECIAL) ATTN: JOSEPH C GRIFFIN III PHONE NO : 856-753-8533 100 STIERLI CT., SUITE 107 SE DECISION MADE: 23-MAR-00 MOUNT ARLINGTON, NJ 07856 510(k) STATEMENT DEVICE: ERECXEL ADJUSTABLE PENILE BANDS, CONTREX ADJUSTABLE PENILE BANDS ERECXEL ENTERPRISES 510(k) NO: K993343(TRADITIONAL) ATTN: PACIFICO R BURGOS PHONE NO : 323-340-8268 3249 SAN FEMANDO RD. SE DECISION MADE: 20-MAR-00 LOS ANGELES, CA 90065 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPIRO PRO ERICH JAEGER GMBH 510(k) NO: K000648(SPECIAL) ATTN: LARRY MURDOCK PHONE NO : 714-283-2228 22705 SAVI RANCH PARKWAY SE DECISION MADE: 29-MAR-00 YORBA LINDA, CA 92887-4645 510(k) STATEMENT DEVICE: DIMENSION GARANT L, DIMENSION GARANT L QUICK ESPE DENTAL AG 510(k) NO: K000588(TRADITIONAL) ATTN: ANDREAS PETERMANN PHONE NO : 011 498 1527001395 ESPE PLATZ SE DECISION MADE: 30-MAR-00 SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIMENSION PENTA H, DIMENSION PENTA H QUICK ESPE DENTAL AG 510(k) NO: K000591(TRADITIONAL) ATTN: ANDREAS PETERMANN PHONE NO : 011 498 1527001395 ESPE PLATZ SE DECISION MADE: 30-MAR-00 SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRACISION HARMONIC SCALPEL SHARP CURVED BLADE/FAST BLADE, MODE ETHICON ENDO-SURGERY, INC. 510(k) NO: K994280(TRADITIONAL) ATTN: RUTH ANN WOOD PHONE NO : 513-337-3468 4545 CREEK RD. SE DECISION MADE: 17-MAR-00 CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BITX PROBES EVEREST MEDICAL CORP. 510(k) NO: K993412(TRADITIONAL) ATTN: FREDERICK G MADES PHONE NO : 612-473-6262 13755 FIRST AVE. NORTH, #500 SE DECISION MADE: 31-MAR-00 MINNEAPOLIS, MN 55441-5454 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POCKET CHAMBER VALVED AEROSOL HOLDING CHAMBER FERRARIS MEDICAL, INC. 510(k) NO: K993199(TRADITIONAL) ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794 555 THIRTEENTH STREET, N.W. SE DECISION MADE: 28-MAR-00 WASHINGTON, DC 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FONAR 360 DEGREE MAGNETIC RESONANCE IMAGING SCANNER FONAR CORP. 510(k) NO: K994287(TRADITIONAL) ATTN: LUCIANO BONANNI PHONE NO : 516-694-2929 110 MARCUS DR. SE DECISION MADE: 16-MAR-00 MELVILLE, NY 11747 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FRESENIUS 2008K FRESENIUS MEDICAL CARE 510(k) NO: K994267(TRADITIONAL) ATTN: ARTHUR EILINSFELD PHONE NO : 781-402-9068 TWO LEDGEMONT CENTER SE DECISION MADE: 16-MAR-00 95 HAYDEN AVENUE 510(k) SUMMARY AVAILABLE FROM FDA LEXINGTON, MA 02420 DEVICE: FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS TPS COATING; FRIADENT GMBH 510(k) NO: K994376(TRADITIONAL) ATTN: CAROL PATTERSON PHONE NO : 949-462-0900 21911 ERIE LANE SE DECISION MADE: 24-MAR-00 LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOLAR 7/8000 GE MARQUETTE MEDICAL SYSTEMS, INC.510(k) NO: K993757(TRADITIONAL) ATTN: KAREN WEBB PHONE NO : 414-362-3329 8200 WEST TOWER AVE. SE DECISION MADE: 23-MAR-00 MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMPACT.WF MOBILE WAVEFORM RECEIVING SYSTEM GE MARQUETTE MEDICAL SYSTEMS, INC.510(k) NO: K994430(TRADITIONAL) ATTN: KAREN WEBB PHONE NO : 414-362-3329 8200 WEST TOWER AVE. SE DECISION MADE: 28-MAR-00 MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VENTRICULAR ANALYSIS TOOLKIT OPTION GE MEDICAL SYSTEM 510(k) NO: K000315(TRADITIONAL) ATTN: LARRY A KROGER PHONE NO : 414-544-3894 P.O. BOX 414 SE DECISION MADE: 27-MAR-00 W-709 510(k) SUMMARY AVAILABLE FROM FDA MILWAUKEE, WI 53201 DEVICE: GE DOLPHIN DIAGNOSTIC ULTRASOUND SYSTEM, ULTRASONIC PULSED DOPPL GE MEDICAL SYSTEMS, INC. 510(k) NO: K000695(TRADITIONAL) ATTN: ALLEN SCHUH PHONE NO : 414-647-4385 P.O. BOX 414 SE DECISION MADE: 16-MAR-00 MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HI GENZYME CORP. 510(k) NO: K000239(TRADITIONAL) ATTN: BARBARA PIZZA PHONE NO : 617-252-7953 ONE KENDALL SQUARE SE DECISION MADE: 21-MAR-00 CAMBRIDGE, MA 02139-1562 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SEPRAMESH BIOSURGICAL COMPOSITE, MODEL SMBC-XXX GENZYME CORP. 510(k) NO: K994328(TRADITIONAL) ATTN: JOHN A DELUCIA PHONE NO : 617-374-7266 ONE KENDALL SQUARE SE DECISION MADE: 02-MAR-00 CAMBRIDGE, MA 02139-1562 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GRASS TS3201/6401 EEG AMPLIFIER SYSTEM GRASS INSTRUMENT CO. 510(k) NO: K994142(TRADITIONAL) ATTN: STEPHEN E JOHNSON PHONE NO : 781-848-2970 570 LIBERTY ST. SE DECISION MADE: 06-MAR-00 BRAINTREE, MA 02185 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 5F GUIDING CATHETER GUIDANT CORP. 510(k) NO: K000598(SPECIAL) ATTN: MARGARET ANDERSON PHONE NO : 408-845-3995 3200 LAKESIDE DR. SE DECISION MADE: 24-MAR-00 SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HARDYDISK TICARILLIN 75MCG HARDY DIAGNOSTICS 510(k) NO: K000175(TRADITIONAL) ATTN: MELISSA M TRAYLOR PHONE NO : 805-346-2766 1430 WEST MCCOY LANE SE DECISION MADE: 02-MAR-00 SANTA MARIA, CA 93455 510(k) STATEMENT DEVICE: HARDYDISK, CARBENICILLIN, 100MCG HARDY DIAGNOSTICS 510(k) NO: K000181(TRADITIONAL) ATTN: MELISSA M TRAY PHONE NO : 805-346-2766 1430 WEST MCCOY LANE SE DECISION MADE: 02-MAR-00 SANTA MARIA, CA 93455 510(k) STATEMENT DEVICE: HARDYDISK, KANAMYCIN, 30MCG HARDY DIAGNOSTICS 510(k) NO: K000203(TRADITIONAL) ATTN: MELISSA TRAYLOR PHONE NO : 805-346-2766 1430 WEST MCCOY LANE SE DECISION MADE: 21-MAR-00 SANTA MARIA, CA 93455 510(k) STATEMENT DEVICE: HARDYDISK, CIPROFLOXACIN, 5MCG HARDY DIAGNOSTICS 510(k) NO: K000258(TRADITIONAL) ATTN: MELISSA M TRAYLOR PHONE NO : 805-346-2766 1430 WEST MCCOY LANE SE DECISION MADE: 21-MAR-00 SANTA MARIA, CA 93455 510(k) STATEMENT DEVICE: HARDYDISK, CEFTAZIDIME, 30MCG HARDY DIAGNOSTICS 510(k) NO: K000259(TRADITIONAL) ATTN: MELISSA M TRAYLOR PHONE NO : 805-346-2766 1430 WEST MCCOY LANE SE DECISION MADE: 21-MAR-00 SANTA MARIA, CA 93455 510(k) STATEMENT DEVICE: HARDY DISK, PENICILLIN, 10 UNITS HARDY DIAGNOSTICS 510(k) NO: K000302(TRADITIONAL) ATTN: MELISSA M TRAYLOR PHONE NO : 805-346-2766 1430 WEST MCCOY LANE SE DECISION MADE: 24-MAR-00 SANTA MARIA, CA 93455 510(k) STATEMENT DEVICE: HARDYDISK, TETRACYCLINE 30MCG HARDY DIAGNOSTICS 510(k) NO: K000304(TRADITIONAL) ATTN: MELISSA M TRAYLOR PHONE NO : 805-346-2766 1430 WEST MCCOY LANE SE DECISION MADE: 29-MAR-00 SANTA MARIA, CA 93455 510(k) STATEMENT DEVICE: HARDYDISK, CEFOXITIN, 30MCG HARDY DIAGNOSTICS 510(k) NO: K000305(TRADITIONAL) ATTN: MELISSA M TRAYLOR PHONE NO : 805-346-2766 1430 WEST MCCOY LANE SE DECISION MADE: 31-MAR-00 SANTA MARIA, CA 93455 510(k) STATEMENT DEVICE: EUB-6000 ULTRASOUND DIAGNOSTIC SCANNER HITACHI MEDICAL CORP. OF AMERICA 510(k) NO: K994026(TRADITIONAL) ATTN: CHARLES F HOTTINGER PHONE NO : 408-741-1006 19030 PORTOS DRIVE SE DECISION MADE: 29-MAR-00 SARATOGA, CA 95070 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AIRIS II HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K994378(TRADITIONAL) ATTN: DOUGLAS J THISTLETHWAITE PHONE NO : 330-425-1313 1959 SUMMIT COMMERCE PARK SE DECISION MADE: 07-MAR-00 TWINSBURG, OH 44087-2371 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE HOMMED SENTRY, MODEL 1 SENTRY HOMMED LLC 510(k) NO: K993938(TRADITIONAL) ATTN: HERSCHEL PEDDICORD PHONE NO : 414-783-5440 19275 WEST CAPITOL DRIVE SE DECISION MADE: 15-MAR-00 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA BROOKFIELD, WI 53045 DEVICE: DURACON SYMMETRIC METAL-BACKED PATELLAR COMPONENT HOWMEDICA OSTEONICS CORP. 510(k) NO: K000091(TRADITIONAL) ATTN: TERRY SHERIDAN POWELL PHONE NO : 201-934-4375 59 ROUTE 17 SE DECISION MADE: 10-MAR-00 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SCORPIO TOTAL STABLIZER (TS) TOTAL KNEE SYSTEM HOWMEDICA OSTEONICS CORP. 510(k) NO: K994128(TRADITIONAL) ATTN: TERRY SHERIDAN POWELL PHONE NO : 201-934-4375 59 ROUTE 17 SE DECISION MADE: 06-MAR-00 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE HOWMEDICA OSTEONICS CORP. 510(k) NO: K994207(TRADITIONAL) ATTN: MARY-CATHERINE DILLON PHONE NO : 201-760-8117 59 ROUTE 17 SE DECISION MADE: 13-MAR-00 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CENTAUR SPINAL SYSTEM HOWMEDICA OSTEONICS CORP. 510(k) NO: K994347(TRADITIONAL) ATTN: MARY-CATHERINE DILLON PHONE NO : 201-760-8117 59 ROUTE 17 SE DECISION MADE: 15-MAR-00 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TMZF PRESS FIT HA STEM AND TMZF PRESS FIT PLUS HA STEM HOWMEDICA OSTEONICS CORP. 510(k) NO: K994366(TRADITIONAL) ATTN: NANCY J RIEDER PHONE NO : 201-507-7956 359 VETERANS BLVD. SE DECISION MADE: 16-MAR-00 RUTHERFORD, NJ 07070-2584 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIDE DRAFT NEB-U-MIST NEBULIZER, MODEL 41896 HUDSON RESPIRATORY CARE, INC. 510(k) NO: K994352(TRADITIONAL) ATTN: JEANNIE DENNING PHONE NO : 909-676-5611 27711 DIAZ RD. SE DECISION MADE: 22-MAR-00 TEMECULA, CA 92589-9020 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYDROCISION DEBDRIDEMENT SYSTEM HYDROCISION, INC. 510(k) NO: K991383(TRADITIONAL) ATTN: DEBBIE IAMPIETRO PHONE NO : 508-435-9893 7 TIFFANY SE DECISION MADE: 31-MAR-00 HOPKINTON, MA 01748 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOAKER CATHETER I-FLOW CORP. 510(k) NO: K994374(TRADITIONAL) ATTN: STANLEY E FRY PHONE NO : 949-206-2700 20202 WINDROW DR. SE DECISION MADE: 03-MAR-00 LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODEL 445SI-64E QUADRATURE WRIST COIL IGC-MEDICAL ADVANCES, INC. 510(k) NO: K000589(TRADITIONAL) ATTN: THOMAS E TYNES PHONE NO : 414-258-3808 10437 INNOVATION DRIVE SE DECISION MADE: 14-MAR-00 MILWAUKEE, WI 53226 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C- IMATRON, INC. 510(k) NO: K000359(TRADITIONAL) ATTN: J.A. CODUTO PHONE NO : 503-638-5500 389 OYSTER POINT BLVD. SE DECISION MADE: 17-MAR-00 SOUTH SAN FRANCISCO, CA 94080 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MLC FIT IMPAC MEDICAL SYSTEMS, INC. 510(k) NO: K991133(TRADITIONAL) ATTN: THOMAS FARIS PHONE NO : 650-254-4700 215 CASTRO ST. SE DECISION MADE: 27-MAR-00 MOUNTAIN VIEW, CA 94041 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: I-PLANT, MODEL 3500 IMPLANT SCIENCES CORP. 510(k) NO: K994317(TRADITIONAL) ATTN: HOWARD L SCHRAYER PHONE NO : 609-924-9510 107 AUDUBON ROAD, #5 SE DECISION MADE: 21-MAR-00 WAKEFIELD, MA 01880-1246 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CROSS LINKED POLYETHYLENE ACETABULAR COMPONENTS,MODEL XX-YY-ZZZZ IMPLEX CORP. 510(k) NO: K990330(TRADITIONAL) ATTN: ROBERT POGGIE PHONE NO : 201-818-1800 80 COMMERCE DR. SE DECISION MADE: 01-MAR-00 ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INVIGRA MALE LATEX CONDOM GREEN COLORED AND MINT FLAVORED INDUS MEDICARE LTD. 510(k) NO: K000038(ABBREVIATED) ATTN: P.K. REDDY PHONE NO : 914 077 60241 144, S.P. RD., BEGUMPET SE DECISION MADE: 21-MAR-00 HYDERABAD ANDHRA PRADESH, INDIA 50510(k) STATEMENT DEVICE: INVIGRA MALE LATEX CONDOM YELLOW COLORED AND BANANA FLAVORED INDUS MEDICARE LTD. 510(k) NO: K000039(ABBREVIATED) ATTN: P.K. REDDY PHONE NO : 914 077 60241 144, S.P. RD., BEGUMPET SE DECISION MADE: 21-MAR-00 HYDERABAD ANDHRA PRADESH, INDIA 50510(k) STATEMENT DEVICE: INVIGRA MALE LATEX CONDOM BLUE COLORED AND VANILLA FLAVORED INDUS MEDICARE LTD. 510(k) NO: K000040(ABBREVIATED) ATTN: P.K. REDDY PHONE NO : 914 077 60241 144, S.P. RD., BEGUMPET SE DECISION MADE: 21-MAR-00 HYDERABAD ANDHRA PRADESH, INDIA 50510(k) STATEMENT DEVICE: RTLX INFIMED, INC. 510(k) NO: K992392(TRADITIONAL) ATTN: RALPH FLATAU PHONE NO : 315-453-4545 121 METROPOLITAN DR. SE DECISION MADE: 31-MAR-00 LIVERPOOL, NY 13088 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACL 9000 SYSTEM INSTRUMENTATION LABORATORY CO. 510(k) NO: K000053(TRADITIONAL) ATTN: CAROL MARBLE PHONE NO : 781-861-4467 113 HARTWELL AVE. SE DECISION MADE: 15-MAR-00 LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTERACOUSTICS AT235 IMPEDANCE AUDIOMETER INTERNATIONAL DISTRIBUTORS OF ELEC510(k) NO: K994254(TRADITIONAL) ATTN: DONNA WARD PHONE NO : 800-947-6334 4814 EAST SECOND STREET SE DECISION MADE: 14-MAR-00 BENICIA, CA 94510 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLASTOCYST FREEZE MEDIUM, BLASTOCYST THAW MEDIUM IRVINE SCIENTIFIC SALES CO., INC. 510(k) NO: K000309(TRADITIONAL) ATTN: ROBERTA L JOHNSON PHONE NO : 800-437-5706 2511 DAIMLER ST. SE DECISION MADE: 13-MAR-00 SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MANUAL DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-502 JAWON MEDICAL CO., LTD. 510(k) NO: K000675(TRADITIONAL) ATTN: ROBERT D WAXHAM PHONE NO : 757-365-0978 222 INSTITUTE ST. SE DECISION MADE: 14-MAR-00 SMITHFIELD, VA 23430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BUILD-IT FR JENERIC/PENTRON, INC. 510(k) NO: K000211(TRADITIONAL) ATTN: ANNMARIE TENERO PHONE NO : 203-265-7397 53 NORTH PLAINS INDUSTRIAL RD. SE DECISION MADE: 17-MAR-00 P.O. BOX 724 510(k) SUMMARY AVAILABLE FROM FDA WALLINGFORD, CT 06492-0724 DEVICE: BOND 1 C & B JENERIC/PENTRON, INC. 510(k) NO: K994359(TRADITIONAL) ATTN: ANNMARIE TENERO PHONE NO : 203-265-7397 53 NORTH PLAINS INDUSTRIAL RD. SE DECISION MADE: 21-MAR-00 P.O. BOX 724 510(k) SUMMARY AVAILABLE FROM FDA WALLINGFORD, CT 06492-0724 DEVICE: CODMAN ETHISORB DURA PATCH JOHNSON & JOHNSON PROFESSIONALS, I510(k) NO: K991413(TRADITIONAL) ATTN: DEANA BOUSHELL PHONE NO : 508-828-3107 325 PARAMOUNT DR. SE DECISION MADE: 13-MAR-00 RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BROTHERS POWDER-FREE VINYL EXAMINATION GLOVES KAOHSIUNG BROTHERS PRODUCTS CORP. 510(k) NO: K000058(TRADITIONAL) ATTN: STONE CHEN PHONE NO : 886 075 612201 23 KOOSHAN 3RD RD. SE DECISION MADE: 10-MAR-00 KAOHSIUNG, CHINA (TAIWAN) 80414 510(k) STATEMENT DEVICE: KSEA SCB-RUI KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K994348(TRADITIONAL) ATTN: KEVIN KENNAN PHONE NO : 310-410-2769 600 CORPORATE POINTE SE DECISION MADE: 03-MAR-00 CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KAWASUMI LABORATORIES PHILEBOTOMY SET KAWASUMI LABORATORIES CO., LTD. 510(k) NO: K994323(TRADITIONAL) ATTN: DONALD R STONE PHONE NO : 202-496-7620 1900 K STREET N.W. SE DECISION MADE: 08-MAR-00 WASHINGTON, DC 20006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR KENDALL CO. 510(k) NO: K000087(TRADITIONAL) ATTN: REGINA YEH PHONE NO : 508-261-8000 15 HAMPSHIRE STREET SE DECISION MADE: 17-MAR-00 MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080 LABTICIAN OPHTHALMICS, INC. 510(k) NO: K000544(TRADITIONAL) ATTN: R. DAVID SCULATI PHONE NO : 905 829 0055 2140 WINSTON PARK DR., UNIT 6 SE DECISION MADE: 09-MAR-00 OAKVILLE, ONTARIO, CANADA L6H 5V5 510(k) STATEMENT DEVICE: MODIFIED HYDROPHILIC COATED GUIDEWIRE LAKE REGION MFG., INC. 510(k) NO: K000011(SPECIAL) ATTN: JIM KLOSTERMAN PHONE NO : 612-448-5111 340 LAKE HAZELTINE DR. SE DECISION MADE: 01-MAR-00 CHASKA, MN 55318 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORION SERIES SURGICAL LASER SYSTEM (SL SERIESQ-SWITCHED ND:YAG LASERSCOPE 510(k) NO: K990718(TRADITIONAL) ATTN: PAUL H HARDIMAN PHONE NO : 800-243-9384 3052 ORCHARD DR. SE DECISION MADE: 08-MAR-00 SAN JOSE, CA 95134-2011 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIFECORE SINGLE TOOTH ABUTMENT SYSTEM LIFECORE BIOMEDICAL, INC. 510(k) NO: K993894(TRADITIONAL) ATTN: CAROLYN ANDERSON PHONE NO : 612-368-6324 3515 LYMAN BLVD. SE DECISION MADE: 08-MAR-00 CHASKA, MN 55318 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MACHIDA FLEXIBLE NEURO-ENDOSCOPE, MODELS NEU-4, NEU-4L MACHIDA ENDOSCOPE CO., LTD. 510(k) NO: K993568(TRADITIONAL) ATTN: GENICHI KANAI PHONE NO : 339 462 621 13-8, HONKOMAGOME 6-CHOME, SE DECISION MADE: 13-MAR-00 BUNKYO-KU 510(k) SUMMARY AVAILABLE FROM FDA TOKYO, JAPAN DEVICE: UBAS MARUKIN DIAGNOSTICS 510(k) NO: K993941(TRADITIONAL) ATTN: GREG HOLLAND PHONE NO : 949-262-0411 3722 AVE. SAUSALITO SE DECISION MADE: 02-MAR-00 IRVINE, CA 92606 510(k) STATEMENT DEVICE: ENDOSCOPIC ANTI FOG DEVICE MECTRA LABS, INC. 510(k) NO: K993604(TRADITIONAL) ATTN: CHARLES E ALLGOOD PHONE NO : 812-384-3521 HIGHWAY 231 SOUTH, SE DECISION MADE: 03-MAR-00 2 QUALITY WAY 510(k) STATEMENT BLOOMFIELD, IN 47424 DEVICE: MEDAMICUS EPIDURAL INTRODUCER MEDAMICUS, INC. 510(k) NO: K994097(TRADITIONAL) ATTN: DENNIS MANSON PHONE NO : 612-559-2613 15301 HWY. 55 WEST SE DECISION MADE: 01-MAR-00 MINNEAPOLIS, MN 55447 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHALANGEAL FIXATION SYSTEM MEDCANICA, INC. 510(k) NO: K994232(TRADITIONAL) ATTN: AL WEISENBORN PHONE NO : 305-829-3437 19526 EAST LAKE DRIVE SE DECISION MADE: 01-MAR-00 MIAMI, FL 33015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIGHTSURE OPERATION INDICATOR, MODEL SS301 MEDEVICES, INC. 510(k) NO: K993358(TRADITIONAL) ATTN: MICHELE H VOVOLKA PHONE NO : 847-856-0355 PO BOX 848 SE DECISION MADE: 15-MAR-00 GRAYSLAKE, IL 60030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDI-CULT ACIDIFIED TYRODES SOLUTION- MEDIUM; INTERNAL CATALOG N MEDI-CULT A/S 510(k) NO: K991470(TRADITIONAL) ATTN: RONALD G LEONARDI PHONE NO : 619-586-0751 9915 CAM. CHIRIMOLLA SE DECISION MADE: 07-MAR-00 SAN DIEGO, CA 92131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SLENDAIR 4000 COMPRESSION SYSTEM MEDICAL COMPRESSION SYSTEMS (D.B.N510(k) NO: K994057(TRADITIONAL) ATTN: SHOSHANA FRIEDMAN PHONE NO : 972 977 18130 117 AHUZAH ST. SE DECISION MADE: 03-MAR-00 RA'ANANNA, ISRAEL 43373 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403,
MEDICAL DATA ELECTRONICS, INC. 510(k) NO: K000660(SPECIAL)
ATTN: CEDRIC NAVARRO PHONE NO : 818-768-6411
12720 WENTWORTH ST. SE DECISION MADE: 28-MAR-00
ARLETA, CA 91331 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMAGE X-70 PLUS DENTAL X-RAY UNIT
MEDICAL DEVICE CONSULTANTS, INC. 510(k) NO: K000551(SPECIAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 16-MAR-00
NORTH ATTLEBORO, MA 02760-4153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UMBILICAL CORD CLAMP
MEDICAL SALES CO. 510(k) NO: K994367(TRADITIONAL)
ATTN: JOHN E LINCOLN PHONE NO : 435-882-4655
P.O. BOX 154 SE DECISION MADE: 17-MAR-00
TOOELE, UT 84074-0154 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MSP M/K BLADE
MEDICAL STERILE PRODUCTS INC. 510(k) NO: K993122(TRADITIONAL)
ATTN: GARY C DIONNE PHONE NO :
RD. 413, KM. 0.2 SE DECISION MADE: 16-MAR-00
RINCON, PR 00677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MRI- FLOW ANALYTICAL SOFTWARE PACKAGE
MEDIS MEDICAL IMAGING SYSTEMS, B.V510(k) NO: K994282(TRADITIONAL)
ATTN: J.I. HOLLANDER PHONE NO : 317 152 3244
POORTGEBOUW RIJNSBURGERWEG 10 SE DECISION MADE: 02-MAR-00
2333 AA LEIDEN 510(k) SUMMARY AVAILABLE FROM FDA
, NETHERLANDS
DEVICE: MCA-601, C-ARM MOBILE
MEDISON RADIOLOGY SYSTEMS, INC. 510(k) NO: K993896(TRADITIONAL)
ATTN: JOHN W LEE PHONE NO : 847-729-3333
2000 LEHIGH AVE. SE DECISION MADE: 27-MAR-00
GLENVIEW, IL 60025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SINGLE SIZE TENDON SPACER
MEDIST INTERNATIONAL 510(k) NO: K000019(TRADITIONAL)
ATTN: BERNARD F GRISONI PHONE NO : 901-380-9411
9160 HIGHWAY 64 SE DECISION MADE: 29-MAR-00
SUITE 12 510(k) SUMMARY AVAILABLE FROM FDA
LAKELAND, TN 38002
DEVICE: REVERSO
MEDISYSTEMS CORP. 510(k) NO: K994306(TRADITIONAL)
ATTN: FREDRIC G SWINDLER PHONE NO : 206-621-6526
1201 3RD AVE., SUITE 3900 SE DECISION MADE: 20-MAR-00
SEATTLE, WA 98101-3016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDLINE BREATHABLE, IMPERVIOUS DISPOSABLE SURGICAL GOWNS
MEDLINE INDUSTRIES, INC. 510(k) NO: K993170(TRADITIONAL)
ATTN: BETTY A LOCK PHONE NO : 847-949-3109
1170 NORTHPOINT BLVD. SE DECISION MADE: 02-MAR-00
WAUKEGAN, IL 60085 510(k) STATEMENT
DEVICE: VACUFLOW+ BLOOD COLLECTION SET, MODEL 52221/3/5; VACUFLOW+ WITH
MEDPRO TECHNOLOGIES, INC. 510(k) NO: K000369(TRADITIONAL)
ATTN: ART WARD PHONE NO : 813-645-2855
962 ALLEGRO LANE SE DECISION MADE: 30-MAR-00
APOLLO BEACH, FL 33572 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOVE LOCKERS
MEDTECH PRODUCTS LTD. 510(k) NO: K993733(ABBREVIATED)
ATTN: A.V.K. REDDY PHONE NO : 009 144 6288829
S-59 20TH STREET SE DECISION MADE: 20-MAR-00
ANNA NAGAR WEST 510(k) SUMMARY AVAILABLE FROM FDA
CHENNAI, INDIA 600 040
DEVICE: DOUBLE SPRINGERS
MEDTECH PRODUCTS LTD. 510(k) NO: K993735(ABBREVIATED)
ATTN: A.V.K. REDDY PHONE NO : 914 462 88829
S-59 20TH STREET SE DECISION MADE: 20-MAR-00
ANNA NAGAR WEST 510(k) SUMMARY AVAILABLE FROM FDA
CHENNAI, INDIA 600 040
DEVICE: MIGHTY MAN (DYNAMIC LINKERS)
MEDTECH PRODUCTS LTD. 510(k) NO: K993737(ABBREVIATED)
ATTN: A.V.K. REDDY PHONE NO : 009 144 6288829
S-59 20TH STREET SE DECISION MADE: 20-MAR-00
ANNA NAGAR WEST 510(k) SUMMARY AVAILABLE FROM FDA
CHENNAI, INDIA 600 040
DEVICE: MODIFICATION TO CD SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K000453(SPECIAL)
ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PL. SE DECISION MADE: 10-MAR-00
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO CD SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K000476(SPECIAL)
ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PL. SE DECISION MADE: 10-MAR-00
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDTRONIC SOLAN FIBEROPTIC CORNEAL LIGHT PROBE
MEDTRONIC XOMED 510(k) NO: K000728(TRADITIONAL)
ATTN: DAVID TIMLIN PHONE NO : 904-279-7532
6743 SOUTHPOINT DR. N. SE DECISION MADE: 21-MAR-00
JACKSONVILLE, FL 32216 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZUMA GUIDE CATHETERS
MEDTRONIC, INC. 510(k) NO: K000677(SPECIAL)
ATTN: FRED L BOUCHER PHONE NO : 978-777-0042
35-37A CHERRY HILL DR. SE DECISION MADE: 29-MAR-00
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MERCURY MEDICAL DISPOSABLE RADIOFREQUENCY CANNULA
MERCURY MEDICAL 510(k) NO: K000073(TRADITIONAL)
ATTN: MATTHEW NEKOROSKI PHONE NO : 978-821-6178
160 SOUTH MAIN STREET SE DECISION MADE: 01-MAR-00
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
MIDDLETON, MA 01949
DEVICE: MODIFICATION TO SOFTOUCH DIAGNOSTIC INTRAVASCULAR CAT
MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K000659(SPECIAL)
ATTN: CHESTER MCCOY PHONE NO : 801-253-1600
1111 SOUTH VELASCO SE DECISION MADE: 29-MAR-00
ANGLETON, TX 77515 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IN-LINE HEMOSTASIS VALVE
MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K990975(TRADITIONAL)
ATTN: CHESTER MCCOY PHONE NO : 801-253-1600
1600 WEST MERIT PKWY. SE DECISION MADE: 15-MAR-00
SOUTH JORDAN, UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICRINS MICROSURGICAL SUTURE
MICRINS MICROSURGICAL INSTRUMENTS,510(k) NO: K993970(TRADITIONAL)
ATTN: BERNHARD TEITZ PHONE NO : 847-549-1410
28438 BALLARD DR. SE DECISION MADE: 30-MAR-00
LAKE FOREST, IL 60045 510(k) STATEMENT
DEVICE: MDI DS-DNA TEST
MICRO DETECT, INC. 510(k) NO: K000477(TRADITIONAL)
ATTN: MEHDI ALEM PHONE NO : 714-832-8234
2852 WALNUT AVE. SE DECISION MADE: 01-MAR-00
TUSTIN, CA 92780 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIKRO-TIP ANGIOGRAPHIC CATHETER
MILLAR INSTRUMENTS, INC. 510(k) NO: K993694(SPECIAL)
ATTN: MIRIELLE ARCE PHONE NO : 713-923-9171
6001 GULF FREEWAY, #534-G SE DECISION MADE: 01-MAR-00
HOUSTON, TX 77023-5417 510(k) STATEMENT
DEVICE: ALLON 2000
MTRE ADVANCED TECHNOLOGY LTD. 510(k) NO: K992386(TRADITIONAL)
ATTN: SHOSHANA FRIEDMAN PHONE NO : 972 977 18130
117 AHUZAH ST SE DECISION MADE: 07-MAR-00
RAANANNA, ISRAEL 43373 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTISAFE POWDERED LATEX EXAMINATION GLOVES, NONSTERILE
MULTISAFE SDN BHD 510(k) NO: K993811(TRADITIONAL)
ATTN: GOH SEOK HUEI PHONE NO : 054 348 269
LOT 764 SE DECISION MADE: 02-MAR-00
BIDOR INDUSTRIAL ESTATE 510(k) STATEMENT
BIDOR, PERAK DARUL RIDZUAN, MALAYSIA 35500
DEVICE: MALLINCKRODT, GOODKNIGHT 418A, GOODKNIGHT 418P, SILVERLINING 2
NELLCOR PURITAN BENNETT FRANCE DVP510(k) NO: K993584(ABBREVIATED)
ATTN: MOUSTAFA ANKI PHONE NO : 333 834 48500
10 ALLEE PELLETIER DOISY SE DECISION MADE: 07-MAR-00
VILLERS-LES-NANCY, FRANCE 54601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRANEMARK NOVUM
NOBEL BIOCARE USA, INC. 510(k) NO: K000018(TRADITIONAL)
ATTN: KATHLEEN DRAGOVICH PHONE NO : 714-282-4800
22725 SAVI RANCH PKWY. SE DECISION MADE: 30-MAR-00
YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVA CORDLESS CURING LIGHT
NOVA/DA VINCI SYSTEMS INC. 510(k) NO: K000393(TRADITIONAL)
ATTN: ALAN A CREAMER PHONE NO : 858-558-9203
9885 MESA RIM SE DECISION MADE: 27-MAR-00
SUITE 127 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92121
DEVICE: SONOGRAPHIC PLANNING OF ONCOLOGY TREATMENTS (SPOT), MODEL V.. 1.
NUCLETRON CORP. 510(k) NO: K992303(TRADITIONAL)
ATTN: RALPH E SHUPING PHONE NO : 410-312-4100
7080 COLUMBIA GATEWAY DR. SE DECISION MADE: 27-MAR-00
COLUMBIA, MD 21046-2133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GAS FILTER
OLSON MEDICAL SALES, INC. 510(k) NO: K993060(TRADITIONAL)
ATTN: GARRY A COURTNEY PHONE NO : 410-392-7231
2101 COTTONTAIL LANE SE DECISION MADE: 28-MAR-00
SOMERSET, NJ 08873 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BACT/ALERT MB CULTURE BOTTLE
ORGANON TEKNIKA CORP. 510(k) NO: K000378(TRADITIONAL)
ATTN: REBECCA A RIVAS PHONE NO : 919-620-2288
100 AKZO AVE. SE DECISION MADE: 02-MAR-00
DURHAM, NC 27712 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHO DEVELOPMENT BALANCED KNEE SYSTEM
ORTHO DEVELOPMENT CORP. 510(k) NO: K994370(TRADITIONAL)
ATTN: CAROL FREASIER PHONE NO : 801-553-9991
106 WEST 12200 SOUTH SE DECISION MADE: 24-MAR-00
DRAPER, UT 84020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K000566(SPECIAL)
ATTN: JOSEPH FALVO PHONE NO : 716-453-5735
100 INDIGO CREEK DR. SE DECISION MADE: 09-MAR-00
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGELLAN TIBIAL INTRAMEDULLARY NAIL
ORTHOMATRIX, INC. 510(k) NO: K992850(TRADITIONAL)
ATTN: BEN SHAPPLEY PHONE NO : 901-888-5614
711 CHANEY COVE SE DECISION MADE: 10-MAR-00
COLLIERVILLE, TN 38017 510(k) STATEMENT
DEVICE: MAGELLAN HUMERAL INTRAMEDULLARY NAIL
ORTHOMATRIX, INC. 510(k) NO: K992856(TRADITIONAL)
ATTN: BEN SHAPPLEY PHONE NO : 901-888-5614
711 CHANEY COVE SE DECISION MADE: 10-MAR-00
COLLIERVILLE, TN 38017 510(k) STATEMENT
DEVICE: CYTOPLAST RESORB, MODELS R-250, RP-250, RU-250, RPS-250, RPL-250
OSTEOGENICS BIOMEDICAL, INC. 510(k) NO: K993610(TRADITIONAL)
ATTN: RICHARD A HAMER PHONE NO : 817-294-3644
6401 MEADOWS WEST DR SE DECISION MADE: 02-MAR-00
FORT WORTH, TX 76132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VOYAGER/VIPER WHEELCHAIR
OTTO BOCK ORTHOPEDIC INDUSTRY, INC510(k) NO: K000497(TRADITIONAL)
ATTN: JOHN HENDRICKSON PHONE NO : 612-553-9464
3000 XENIUM LN. NORTH SE DECISION MADE: 08-MAR-00
MINNEAPOLIS, MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROTEGE WHEELCHAIR
OTTO BOCK ORTHOPEDIC INDUSTRY, INC510(k) NO: K000602(TRADITIONAL)
ATTN: JOHN HENDRICKSON PHONE NO : 612-553-9464
3000 XENIUM LN. NORTH SE DECISION MADE: 03-MAR-00
MINNEAPOLIS, MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THROMBOSTRATE CONTROL PLASMAS
PACIFIC HEMOSTASIS 510(k) NO: K000679(TRADITIONAL)
ATTN: LAURA A WORFOLK PHONE NO : 704-948-3276
11515 VANSTORY DR. SE DECISION MADE: 24-MAR-00
HUNTERSVILLE, NC 28078-8144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PACIFIC SURGICAL PATTIES
PACIFIC SURGICAL INNOVATIONS, INC.510(k) NO: K993019(TRADITIONAL)
ATTN: TERRY JOHNSTON PHONE NO : 650-802-6938
360 INDUSTRIAL RD., UNIT H SE DECISION MADE: 30-MAR-00
SAN CARLOS, CA 94070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNIPOLAR NEEDLES
PAJUNK GMBH 510(k) NO: K000722(TRADITIONAL)
ATTN: BURK A BRANDT PHONE NO : 541-752-9393
5010 NW CRESCENT VALLEY DRIVE SE DECISION MADE: 31-MAR-00
CORVALLIS, OR 97330 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEALTH-PLUS, SANITEX, RELIANCE POWEDER-FREE STERILE LATEX SURGIC
PAMITEX INDUSTRIES SDN BHD 510(k) NO: K993201(TRADITIONAL)
ATTN: SAID AWANG PHONE NO : 606 631 3122
2 1/2 MILES, JALAN RASAH SE DECISION MADE: 29-MAR-00
SEREMBAN, NAGERI SEMBILAN 510(k) STATEMENT
DARUL KHUSUS, MALAYSIA 70300
DEVICE: POSITUBE
PARAPRODUCTS INC. 510(k) NO: K000045(TRADITIONAL)
ATTN: JAMES FLORY PHONE NO : 630-250-7979
1431 INDUSTRIAL DRIVE SE DECISION MADE: 15-MAR-00
ITASCA, IL 60143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUICKSCREEN METHAMPHETAMINE TEST, MODELS 9045, 9046, QUICKSCREEN
PHAMATECH 510(k) NO: K000447(SPECIAL)
ATTN: CARL A MONGIOVI PHONE NO : 858-635-5840
9265 ACTIVITY RD., #112-113 SE DECISION MADE: 07-MAR-00
SAN DIEGO, CA 92126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VARELISA SM ANTIBODIES
PHARMACIA & UPJOHN CO. 510(k) NO: K000312(TRADITIONAL)
ATTN: KAREN MATIS PHONE NO : 614-794-3324
5094 ST. ANDREWS DRIVE SE DECISION MADE: 17-MAR-00
WESTERVILLLE, OH 43082 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PILLING WECK SURGICAL AORTIC SPOON-JAW CLAMP
PILLING WECK SURGICAL 510(k) NO: K992174(TRADITIONAL)
ATTN: RICHARD G JONES PHONE NO : 800-523-6507
420 DELAWARE DR. SE DECISION MADE: 23-MAR-00
FORT WASHINGTON, PA 19034 510(k) STATEMENT
DEVICE: DIMEX 2
PLANMECA OY 510(k) NO: K000454(TRADITIONAL)
ATTN: BOB PIENKOWSKI PHONE NO : 630-595-7077
362 BALM COURT SE DECISION MADE: 31-MAR-00
WOOD DALE, IL 60191-1273 510(k) STATEMENT
DEVICE: MALE LATEX CONDOM WITH VANILLA FLAVOR
PLEASURE LATEX PRODUCTS SDN. BHD. 510(k) NO: K994311(ABBREVIATED)
ATTN: LIM KOI YONG PHONE NO : 603 874 0784
LOT 1365, 17TH MILES, JALAN SE DECISION MADE: 21-MAR-00
SUNGAI SEMBILANG 510(k) STATEMENT
JERAM, SELANGOR, MALAYSIA 45800
DEVICE: MALE LATEX CONDOM 56MM
PLEASURE LATEX PRODUCTS SDN. BHD. 510(k) NO: K994312(ABBREVIATED)
ATTN: LIM KOI YONG PHONE NO : 603 874 0784
LOT 1365, 17TH MILES, JALAN SE DECISION MADE: 21-MAR-00
SUNGAI SEMBILANG 510(k) STATEMENT
JERAM, SELANGOR, MALAYSIA 45800
DEVICE: PORTSETT
PORTSETT, INC. 510(k) NO: K000085(TRADITIONAL)
ATTN: SALVADORE F PALOMARES PHONE NO : 949-463-6146
154 VIA LAMPARA SE DECISION MADE: 17-MAR-00
RANCHO SANTA MARGARITA, CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565
PRECISION DYNAMICS CORP. 510(k) NO: K994353(TRADITIONAL)
ATTN: KALYNA SNYLYK PHONE NO : 818-897-1111
13880 DEL SUR ST. SE DECISION MADE: 22-MAR-00
SAN FERNANDO, CA 91340-3490 510(k) STATEMENT
DEVICE: PROSTEC 125I BRACHYTHERAPY SEEDS
PROSTEC LLC 510(k) NO: K993280(TRADITIONAL)
ATTN: AL WEISENBORN PHONE NO : 305-829-3437
19526 EAST LAKE DRIVE SE DECISION MADE: 14-MAR-00
MIAMI, FL 33015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PULPDENT CAVITY PREPARATION III
PULPDENT CORP. 510(k) NO: K994180(TRADITIONAL)
ATTN: KENNETH J BERK PHONE NO : 617-926-6666
80 OAKLAND ST. SE DECISION MADE: 02-MAR-00
WATERTOWN, MA 02471-0780 510(k) STATEMENT
DEVICE: NELLCOR PURITAN BENNETT 700 SERIES VENTILATOR SYSTEM, AND EASYNE
PURITAN-BENNETT IRELAND, LTD. 510(k) NO: K990897(TRADITIONAL)
ATTN: ROBBIE WALSH PHONE NO : 353 917 53771
MERVUE SE DECISION MADE: 15-MAR-00
GALWAY, IRELAND 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POCKET ULTRASONIC OPHTHALMIC PACHYMETER, BIOMETRY TRANSDUCER FOR
QUANTEL MEDICAL 510(k) NO: K000554(SPECIAL)
ATTN: GEORGE MYERS PHONE NO : 201-727-1703
377 ROUTE 17 SOUTH SE DECISION MADE: 14-MAR-00
HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Q-TEL TELEMETRY SYSTEM V. 6.0 (ST)
QUINTON INSTRUMENT CO. 510(k) NO: K992908(TRADITIONAL)
ATTN: MATTHEW J HEDLUND PHONE NO : 425-402-2416
3303 MONTE VILLA PKWY. SE DECISION MADE: 06-MAR-00
BOTHELL, WA 98021-8906 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RADIONICS LUMBOPERITONEAL SHUNT
RADIONICS, INC. 510(k) NO: K000057(TRADITIONAL)
ATTN: KEVIN K O'CONNELL PHONE NO : 800-466-6814
22 TERRY AVE. SE DECISION MADE: 20-MAR-00
BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEVEEN NEEDLE ELECTRODE
RADIOTHERAPEUTICS CORP. 510(k) NO: K000032(TRADITIONAL)
ATTN: GARY CURTIS PHONE NO : 408-745-3200
1308 BORREGAS AVENUE SE DECISION MADE: 30-MAR-00
SUNNYVALE, CA 94089 510(k) STATEMENT
DEVICE: RANDOX COMPLEMENT C4
RANDOX LABORATORIES LTD. 510(k) NO: K000468(TRADITIONAL)
ATTN: P ARMSTRONG PHONE NO : 440 289 445294
ARDMORE, DIAMOND ROAD SE DECISION MADE: 27-MAR-00
CRUMLIN, BT29 4QY CO. 510(k) STATEMENT
ANTRIM, N. IRELAND, IRAN
DEVICE: RANDOX COMPLEMENT C3
RANDOX LABORATORIES LTD. 510(k) NO: K000469(TRADITIONAL)
ATTN: R ARMSTRONG PHONE NO : 440 289 4422413
ARDMORE, DIAMOND ROAD SE DECISION MADE: 27-MAR-00
CRUMLIN, BT29 4QY CO. 510(k) SUMMARY AVAILABLE FROM FDA
ANTRIM, N. IRELAND, IRELAND
DEVICE: RANDOX ALBUMIN
RANDOX LABORATORIES LTD. 510(k) NO: K000483(TRADITIONAL)
ATTN: P ARMSTRONG PHONE NO : 440 289 4422413
55 DIAMOND RD. SE DECISION MADE: 31-MAR-00
CRUMLIN, CO. ANTRIM, IRELAND BT29 510(k) STATEMENT
DEVICE: REICHERT CT200 CONTACT TONOMETER
REICHERT OPHTHALMIC INSTRUMENTS, D510(k) NO: K000288(TRADITIONAL)
ATTN: FRANK J DREXELIUS PHONE NO : 716-686-4548
3374 WALDEN AVE. SE DECISION MADE: 23-MAR-00
DEPEW, NY 14043 510(k) STATEMENT
DEVICE: M.R. VISION 2000 ULTRA AUDIO VISUAL SYSTEM / COMMANDER X6 SYSTEM
RESONANCE TECHNOLOGY, INC. 510(k) NO: K994351(TRADITIONAL)
ATTN: MOKHTAR ZIARATI PHONE NO : 818-882-1997
18121 PARTHENIA ST. SE DECISION MADE: 22-MAR-00
NORTHRIDGE, CA 91325 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIPAP SYNCHRONY HC
RESPIRONICS GEORGIA, INC. 510(k) NO: K992530(ABBREVIATED)
ATTN: DAVID J VANELLA PHONE NO : 724-733-5866
1001 MURRY RIDGE LANE SE DECISION MADE: 20-MAR-00
MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KNIGHT ENDOSCOPIC SPINE SYSTEM (KESS)
RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K000046(TRADITIONAL)
ATTN: ROBERT L CASARSA PHONE NO : 847-913-1113
353 CORPORATE WOODS PKWY. SE DECISION MADE: 30-MAR-00
VERNON HILLS, IL 60061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSTRUMENTS FOR MINIMALLY INVASIVE SPINAL SURGERY (MISS)
RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K994363(TRADITIONAL)
ATTN: ROBERT L CASARSA PHONE NO : 847-913-1113
353 CORPORATE WOODS PKWY. SE DECISION MADE: 06-MAR-00
VERNON HILLS, IL 60061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RITA RF GENERATOR AND ACCESSORIES, MODEL 500 SERIES
RITA MEDICAL SYSTEMS 510(k) NO: K983214(TRADITIONAL)
ATTN: DAN BALBIERZ PHONE NO : 650-390-8500
967 NORTH SHORELINE BLVD. SE DECISION MADE: 27-MAR-00
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECSYS B-CROSSLAPS CALCHECK
ROCHE DIAGNOSTICS CORP. 510(k) NO: K000042(TRADITIONAL)
ATTN: KAY A LAPS PHONE NO : 317-576-3544
9115 HAGUE ROAD SE DECISION MADE: 17-MAR-00
P.O. BOX 50457 510(k) SUMMARY AVAILABLE FROM FDA
INDIANAPOLIS, IN 46250-0457
DEVICE: ELECSYS CORTISOL TEST SYSTEM
ROCHE DIAGNOSTICS CORP. 510(k) NO: K000270(TRADITIONAL)
ATTN: PRISCILLA A HAMMILL PHONE NO : 317-576-3723
9115 HAGUE RD. SE DECISION MADE: 07-MAR-00
INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECSYS CORTISOL CALCHECK
ROCHE DIAGNOSTICS CORP. 510(k) NO: K000576(TRADITIONAL)
ATTN: KAY A TAYLOR PHONE NO : 317-576-3544
9115 HAGUE RD. SE DECISION MADE: 21-MAR-00
INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMBRYON GIFT TRANSFER CATHETERS/SETS
ROCKET MEDICAL PLC 510(k) NO: K000656(TRADITIONAL)
ATTN: LES TODD PHONE NO : 011 441 914166776
WARE INDUSTRIAL ESTATE SE DECISION MADE: 09-MAR-00
WASHINGTON, TYNE & WEAR, UNITED KI510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEUROTHERM RF CANNULA
ROCKET MEDICAL PLC 510(k) NO: K994344(TRADITIONAL)
ATTN: LES TODD PHONE NO : 011 441 914166776
FACTORIES 3 & 4, SE DECISION MADE: 21-MAR-00
WEAR INDUSTRIAL ESTATE 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, TYNE & WEAR, UNITED KINGDOM NE37 1NE
DEVICE: RUSCH MANUAL RESUSCITATOR BAG
RUSCH, INC. 510(k) NO: K993194(TRADITIONAL)
ATTN: RONALD YOUNG PHONE NO : 770-623-0816
2450 MEADOWBROOK PKWY. SE DECISION MADE: 24-MAR-00
DULUTH, GA 30096 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAS STREP A TEST
SA SCIENTIFIC, INC. 510(k) NO: K993456(TRADITIONAL)
ATTN: HARBI A SHADFAN PHONE NO : 210-699-8800
4919 GOLDEN QUAIL SE DECISION MADE: 07-MAR-00
SAN ANTONIO, TX 78240 510(k) STATEMENT
DEVICE: SOLOGUARD LOCKING PLUS SYRINGE
SAFEGUARD MEDICAL PRODUCTS, INC. 510(k) NO: K993609(TRADITIONAL)
ATTN: PATRICK GRANT PHONE NO : 781-935-2275
52 DRAGON COURT SE DECISION MADE: 17-MAR-00
WOBURN, MA 01801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAFESKIN PFE-XTRA POWDER-FREE LATEX EXAMINATION GLOVES, PROTEIN
SAFESKIN CORP. 510(k) NO: K993117(TRADITIONAL)
ATTN: EUGENE V GOORCHENKO PHONE NO : 619-509-7010
12671 HIGH BLUFF DR. SE DECISION MADE: 02-MAR-00
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IO-DRIVE
SELECTIVE MED COMPONENTS, INC. 510(k) NO: K993081(TRADITIONAL)
ATTN: RICK FISHER PHONE NO : 740-397-7838
6 S. MECHANIC ST. SE DECISION MADE: 03-MAR-00
MOUNT VERNON, OH 43050 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
SELFCARE, INC. 510(k) NO: K000583(SPECIAL)
ATTN: CAROL A ADILETTO PHONE NO : 781-647-3900
200 PROSPECT STREET SE DECISION MADE: 17-MAR-00
WALTHAM, MA 02453 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GEL MARK BIOPSY SITE MARKER, MODELS MKOOO1, MK0004, MK0007
SENORX INC. 510(k) NO: K000060(TRADITIONAL)
ATTN: AMY BOUCLY PHONE NO : 949-454-1300
13766 ALTON PKWY., SUITE 144 SE DECISION MADE: 27-MAR-00
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITAL SHIELD GOLD NON-STERILE POWDERED LATEX EXAM GLOVES BLUE, W
SGMP CO., LTD. 510(k) NO: K000488(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 20-MAR-00
SPARKS, NV 89434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDERED LATEX EXAM GLOVES, PINK, WITH/WITHOUT STRAWBERRY SCENT,
SGMP CO., LTD. 510(k) NO: K000671(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 29-MAR-00
SPARKS, NV 89434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE POWDER FREE NITRILE EXAM GLOVES, WHITE COLOR
SHEEN MORE ENT. CO., LTD. 510(k) NO: K000226(TRADITIONAL)
ATTN: KEN HUANG PHONE NO : 011 886 55575937
NO.16, TOU KUNG SIX RD. SE DECISION MADE: 02-MAR-00
TOU-LIU EXPANDED INDUST. AREA 510(k) STATEMENT
TOU-LIU, YUN-LIN, CHINA (TAIWAN)
DEVICE: SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES
SHIJIAZHUANG GREAT VISION PLASTIC 510(k) NO: K992554(TRADITIONAL)
ATTN: KAREN ABEL PHONE NO : 909-590-9358
13945 MAGNOLIA AVE SE DECISION MADE: 29-MAR-00
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
SHIJIAZHUANG HONGXIANG PLASTICS PR510(k) NO: K992821(TRADITIONAL)
ATTN: KAREN ABELL PHONE NO : 909-548-4828
12390 EAST END AVE SE DECISION MADE: 10-MAR-00
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800 S
SHIMADZU MEDICAL SYSTEMS 510(k) NO: K994431(TRADITIONAL)
ATTN: MICHAEL FISHBACK PHONE NO : 310-217-8855
20101 SOUTH VERMONT AVE. SE DECISION MADE: 23-MAR-00
TORRANCE, CA 90502 510(k) STATEMENT
DEVICE: WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYT
SIMS PORTEX LTD. 510(k) NO: K000628(TRADITIONAL)
ATTN: GILES BISHOP PHONE NO : 44 130 3260551
HYTHE SE DECISION MADE: 13-MAR-00
KENT, UNITED KINGDOM CT21 6JL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VOCOM IMPLANT- 8MM
SMITH & NEPHEW, INC. 510(k) NO: K000533(TRADITIONAL)
ATTN: ALICIA FARAGE PHONE NO : 901-373-0279
2925 APPLING ROAD SE DECISION MADE: 01-MAR-00
BARTLETT, TN 38133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW SUTURELOK, MODEL 7207321
SMITH & NEPHEW, INC. 510(k) NO: K000717(SPECIAL)
ATTN: NICHOLAS CONDAKES PHONE NO : 508-261-3770
130 FORBES BLVD. SE DECISION MADE: 30-MAR-00
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DYONICS ELECTROBLADE
SMITH & NEPHEW, INC. 510(k) NO: K994365(TRADITIONAL)
ATTN: DEBORAH CONNORS PHONE NO : 978-749-1495
160 DASCOMB RD. SE DECISION MADE: 13-MAR-00
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLORADO II SPINAL SYSTEM
SOFAMOR DANEK USA,INC. 510(k) NO: K984360(TRADITIONAL)
ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 30-MAR-00
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECTROSURGICAL GENERATOR, MODEL S1
SOMNUS MEDICAL TECHNOLOGIES, INC. 510(k) NO: K000501(TRADITIONAL)
ATTN: STEVEN J OJALA PHONE NO : 408-617-3434
285 NORTH WOLFE RD. SE DECISION MADE: 17-MAR-00
SUNNYVALE, CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BABY FACE
SONORA MEDICAL SYSTEMS 510(k) NO: K994385(TRADITIONAL)
ATTN: COLLEEN HITTLE PHONE NO : 303-682-5871
1830 BOSTON AVE SE DECISION MADE: 16-MAR-00
SUITE D 510(k) SUMMARY AVAILABLE FROM FDA
LONGMONT, CO 80501
DEVICE: FERTILOSCOPY KIT FH 1.29/FTO 1.40
SOPRANE S.A. 510(k) NO: K992655(TRADITIONAL)
ATTN: HOWARD M HOLSTEIN PHONE NO : 202-637-5813
555 THIRTEENTH ST., N.W. SE DECISION MADE: 13-MAR-00
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S57D DIGITAL OPERATING ROOM CAMERA
SOPRO 510(k) NO: K000422(TRADITIONAL)
ATTN: PIERRE MONTILLOT PHONE NO : 33 491 270727
PLACE ST. CHRISTOPHE SE DECISION MADE: 31-MAR-00
LES ACCATES-LA VALENTINE 510(k) SUMMARY AVAILABLE FROM FDA
MARSEILLE, FRANCE 13011
DEVICE: S52D DIGITAL VIDEO LAPAROSCOPE
SOPRO 510(k) NO: K000423(TRADITIONAL)
ATTN: PIERRE MONTILLOT PHONE NO : 33 491 270727
PLACE ST. CHRISTOPHE SE DECISION MADE: 31-MAR-00
LES ACCATES-LA VALENTINE 510(k) SUMMARY AVAILABLE FROM FDA
MARSEILLE, FRANCE 13011
DEVICE: S51D DIGITAL ENDOSCOPY CAMERA
SOPRO 510(k) NO: K000424(TRADITIONAL)
ATTN: PIERRE MONTILLOT PHONE NO : 33 491 270727
PLACE ST. CHRISTOPHE SE DECISION MADE: 31-MAR-00
LES ACCATES-LA VALENTINE 510(k) SUMMARY AVAILABLE FROM FDA
MARSEILLE, FRANCE 13011
DEVICE: 125-IMPLANT SEEDS, MODEL STM1250
SOURCETECH MEDICAL, L.L.C. 510(k) NO: K991881(TRADITIONAL)
ATTN: DAVID T SIERACKI PHONE NO : 630-933-7610
295 E. LIES RD. SE DECISION MADE: 16-MAR-00
CAROL STREAM, IL 60188 510(k) STATEMENT
DEVICE: SPECIALTY 42 9HEFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEA
SPECIALTY ULTRAVISION, INC. 510(k) NO: K000376(TRADITIONAL)
ATTN: GAROLD L EDWARDS PHONE NO : 408-341-0700
307 ORCHARD CITY DR. SE DECISION MADE: 21-MAR-00
CAMPBELL, CA 95008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAUTERY FORCEPS WITH FOOTSWITCH
STARION INSTRUMENTS 510(k) NO: K000250(TRADITIONAL)
ATTN: BRIAN GRIGSBY PHONE NO : 408-741-8773
20665 4TH ST. SE DECISION MADE: 07-MAR-00
SARATOGA, CA 95070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STARION CAUTERY HOOK
STARION INSTRUMENTS 510(k) NO: K000296(TRADITIONAL)
ATTN: BRIAN GRIGSBY PHONE NO : 408-741-8773
20665 4TH ST. SE DECISION MADE: 07-MAR-00
SARATOGA, CA 95070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUCTION VASCULAR STAPLER AND IMPLANTABLE STAPLE SYSTEM
STD MFG., INC. 510(k) NO: K000608(TRADITIONAL)
ATTN: JIM LOUSARARIAN PHONE NO : 301-594-3090
1063 TURNPIKE ST. SE DECISION MADE: 07-MAR-00
STOUGHTON, MA 02072 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERIS AMSCO MILLENNIUM STEAM STERILIZER
STERIS CORP. 510(k) NO: K000077(SPECIAL)
ATTN: RAYMOND URSICK PHONE NO : 440-392-7016
5960 HEISELY RD. SE DECISION MADE: 17-MAR-00
MENTOR, OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STEAM/EO RECORD CARD, MODEL CI 121
STERITEC PRODUCTS MFG. CO., INC. 510(k) NO: K000502(SPECIAL)
ATTN: LINDA NELSON PHONE NO : 303-660-4201
599 TOPEKA WAY SE DECISION MADE: 14-MAR-00
SUITE 700 510(k) STATEMENT
CASTLE ROCK, CO 80104
DEVICE: SYNOCTA ANGLED ABUTMENTS
STRAUMANN USA 510(k) NO: K994119(TRADITIONAL)
ATTN: LINDA JALBERT PHONE NO : 800-448-8168
RESERVOIR PLACE, SE DECISION MADE: 17-MAR-00
1601 TRAPELO ROAD 510(k) SUMMARY AVAILABLE FROM FDA
WALTHAM, MA 02154
DEVICE: CELL-CHEX
STRECK LABORATORIES, INC. 510(k) NO: K000076(TRADITIONAL)
ATTN: PAUL KITTELSON PHONE NO : 402-333-6017
14124 INDUSTRIAL RD. SE DECISION MADE: 03-MAR-00
OMAHA, NE 68145-0625 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RETIC CHEX LINEARITY
STRECK LABORATORIES, INC. 510(k) NO: K000115(TRADITIONAL)
ATTN: PAUL KITTELSON PHONE NO : 402-691-7465
14124 INDUSTRIAL RD. SE DECISION MADE: 27-MAR-00
OMAHA, NE 68145-0625 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADS
SULZER ORTHOPEDICS, INC. 510(k) NO: K993259(TRADITIONAL)
ATTN: MITCHELL A DHORITY PHONE NO : 512-432-9202
9900 SPECTRUM DR. SE DECISION MADE: 10-MAR-00
AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUPERGLOVES STERILE POWDERED LATEX EXAMINATION GLOVES
SUPERMAX GLOVE MANUFACTURING SDN B510(k) NO: K000644(TRADITIONAL)
ATTN: STANLEY THAI PHONE NO :
47000 SUNGAI BULOH SE DECISION MADE: 17-MAR-00
SELANGOR, MALAYSIA 510(k) STATEMENT
DEVICE: SURGI-VISION ESOPHAGEAL STYLET COIL
SURGI-VISION, INC. 510(k) NO: K994436(TRADITIONAL)
ATTN: NANCY E TAYLOR PHONE NO : 410-730-8998
9250 RUMSEY RD., SUITE 100 SE DECISION MADE: 14-MAR-00
COLUMBIA, MD 21045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RADIOCAMERAS SYSTEM HEAD/NECK APPLICATION
SURGICAL NAVIGATION TECHNOLOGIES, 510(k) NO: K994355(TRADITIONAL)
ATTN: ANGELIQUE S DESTRUEL PHONE NO : 303-439-9709
530 COMPTON ST. SE DECISION MADE: 22-MAR-00
BROOMFIELD, CO 80020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK85
SURGIN SURGICAL INSTRUMENTATION, I510(k) NO: K994015(TRADITIONAL)
ATTN: DON HARR PHONE NO : 714-832-6300
14762 BENTLEY CIRCLE SE DECISION MADE: 15-MAR-00
TUSTIN, CA 92680 510(k) STATEMENT
DEVICE: SUPERSTITCH
SUTURA, INC. 510(k) NO: K994087(TRADITIONAL)
ATTN: DAVE BARRY PHONE NO : 714-437-9801
17080 NEWHOPE ST. SE DECISION MADE: 01-MAR-00
FOUNTAIN VALLEY, CA 92708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BELLEGLASS HP OPACEOUS DENTIN
SYBRON DENTAL SPECIALTIES INC. 510(k) NO: K000269(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVENUE SE DECISION MADE: 23-MAR-00
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BELLEGLASS HP TRANSLUCENT DENTIN
SYBRON DENTAL SPECIALTIES INC. 510(k) NO: K000436(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVENUE SE DECISION MADE: 24-MAR-00
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLO ORTHO 2
SYBRON DENTAL SPECIALTIES INC. 510(k) NO: K994309(TRADITIONAL)
ATTN: WENDY URTEL PHONE NO : 714-516-7425
1717 WEST COLLINS AVENUE SE DECISION MADE: 17-MAR-00
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES (USA) LOCKING CONDYLAR PLATE (LCP) SYSTEM
SYNTHES (USA) 510(k) NO: K000066(TRADITIONAL)
ATTN: SHERI L MUSGNUNG PHONE NO : 610-647-9700
1690 RUSSELL ROAD SE DECISION MADE: 15-MAR-00
POST OFFICE BOX 1766 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301
DEVICE: SYNTHES BUTTON PLATE
SYNTHES (USA) 510(k) NO: K994364(TRADITIONAL)
ATTN: SHERI L MUSGNUNG PHONE NO : 610-647-9700
1690 RUSSELL ROAD SE DECISION MADE: 15-MAR-00
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO SYNTHES USS
SYNTHES SPINE 510(k) NO: K000450(SPECIAL)
ATTN: JONATHAN GILBERT PHONE NO : 610-647-9700
P.O. BOX 0548 SE DECISION MADE: 10-MAR-00
1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301
DEVICE: SYNTHES ANTERIOR CSLP SYSTEM
SYNTHES SPINE 510(k) NO: K000536(SPECIAL)
ATTN: JONATHAN GILBERT PHONE NO : 610-647-9700
P.O. BOX 0548 SE DECISION MADE: 15-MAR-00
1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301
DEVICE: SYNTHES ANTERIOR CSLP SYSTEM
SYNTHES SPINE 510(k) NO: K000742(SPECIAL)
ATTN: JONATHAN GILBERT PHONE NO : 610-647-9700
P.O. BOX 0548 SE DECISION MADE: 29-MAR-00
1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301
DEVICE: SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS
SYVA CO., DADE BEHRING INC. 510(k) NO: K000600(TRADITIONAL)
ATTN: PAUL L ROGERS PHONE NO : 408-239-2309
P.O. BOX 49013 SE DECISION MADE: 27-MAR-00
SAN JOSE, CA 95161-9013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO RTA RETINAL THICKNESS ANALYZER
TALIA TECHNOLOGY LTD. 510(k) NO: K000731(SPECIAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
COLUMBIA SQUARE SE DECISION MADE: 31-MAR-00
555 THIRTEENTH STREET N.W. 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20004-1109
DEVICE: CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULM
TERUMO CORP. 510(k) NO: K993189(TRADITIONAL)
ATTN: GARRY A COURTNEY PHONE NO : 800-283-7866
125 BLUE BALL RD SE DECISION MADE: 01-MAR-00
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TERUMO NEEDLE WITH LOCKING SHEATH
TERUMO MEDICAL CORP. 510(k) NO: K000387(ABBREVIATED)
ATTN: YUK-TING LEWIS PHONE NO : 410-392-7213
125 BLUE BALL ROAD SE DECISION MADE: 02-MAR-00
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TFX MEDICAL INTRODUCER ASSEMBLY
TFX MEDICAL, INC. 510(k) NO: K993191(TRADITIONAL)
ATTN: JULIA A BEAUMONT PHONE NO : 603-532-7706
TALL PINES PARK SE DECISION MADE: 24-MAR-00
JAFFREY, NH 03452 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYCURE ORAL / HYCURE ORAL SMART GEL
THE HYMED GROUP CORP. 510(k) NO: K994339(TRADITIONAL)
ATTN: ANITA M PETITO PHONE NO : 610-865-9876
1890 BUCKNELL DR. SE DECISION MADE: 22-MAR-00
BETHLEHEM, PA 18015 510(k) STATEMENT
DEVICE: NAC Y-ADP
THE KIPP GROUP 510(k) NO: K000343(TRADITIONAL)
ATTN: GARY WERSCHMIDT PHONE NO : 909-390-9080
930 WANAMAKER AVE. SE DECISION MADE: 01-MAR-00
ONTARIO, CA 91761 510(k) STATEMENT
DEVICE: LIFESTYLE MV2 (TM) TORIC (POLYMACON) SOFT (HYDROPHILIC) MULTIFOC
THE LIFESTYLE CO., INC. 510(k) NO: K000529(TRADITIONAL)
ATTN: MARTIN RIEHM PHONE NO : 732-972-8585
712 GINESI DR. SE DECISION MADE: 21-MAR-00
MORGANVILLE, NJ 07751 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLYMPUS XCYF-1T3 OES CYSTOFIBERSCOPE/NEPHROFIBERSCOPE ACCESSORIE
THE OLYMPUS OPTICAL CO. 510(k) NO: K993041(TRADITIONAL)
ATTN: ROBERT SHIFF PHONE NO : 973-227-1830
1129 BLOOMFIELD AVE. SE DECISION MADE: 30-MAR-00
WEST CALDWELL, NJ 07006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NONLINEAR TAPER LAG SCREW
THEKEN SURGICAL 510(k) NO: K994382(TRADITIONAL)
ATTN: LUKAS EISERMANN PHONE NO : 330-753-7451
1100 NOLA AVENUE SE DECISION MADE: 10-MAR-00
BARBERTON, OH 44203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BITEM LOCK, MODELS SW006, SW012
THERMOELASTIC TECHNOLOGIES, INC. 510(k) NO: K994357(TRADITIONAL)
ATTN: ART WARD PHONE NO : 813-645-2855
3234 ELLA LANE SE DECISION MADE: 14-MAR-00
NEW PORT RICHEY, FL 34655 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHILLBUSTER PORTABLE ELECTRIC BLANKET SYSTEM, MODEL 8001
THERMOGEAR, INC. 510(k) NO: K991684(TRADITIONAL)
ATTN: R. WAYNE FIELDS PHONE NO : 503-624-1415
18005 LOWER BOONES FERRY RD. SE DECISION MADE: 01-MAR-00
TIGARD, OR 97224 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AEQUALIS SHOULDER FRACTURE SYSTEM
TORNIER S.A. 510(k) NO: K994392(TRADITIONAL)
ATTN: DAVID W SCHLERF PHONE NO : 925-356-2640
200 GREGORY LANE SE DECISION MADE: 10-MAR-00
SUITE C-100 510(k) SUMMARY AVAILABLE FROM FDA
PLEASANT HILL, CA 94523-3389
DEVICE: SUPERGUARD SAFETY SYRINGE
U.S. SAFETY SYRINGES CO., INC. 510(k) NO: K990831(TRADITIONAL)
ATTN: JAMES GINESI PHONE NO : 954-561-9500
1290 EAST OAKLAND PARK BLVD. SE DECISION MADE: 08-MAR-00
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
FORT LAUDERDALE, FL 33334-4447
DEVICE: ULTICARE DISPOSABLE SYRINGE
ULTIMED, INC. 510(k) NO: K994230(TRADITIONAL)
ATTN: CHARLES W ERICKSON PHONE NO : 651-291-7909
287 EAST 6TH STREET SE DECISION MADE: 24-MAR-00
ST. PAUL, MN 55101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3S INJECTOR-CT CONTRAST DELIVERY SYSTEM
UNIMACHS CORP. 510(k) NO: K983826(TRADITIONAL)
ATTN: EDUARDO MARCH PHONE NO : 301-986-4440
7475 WISCONSIN AVENUE, SE DECISION MADE: 23-MAR-00
SUITE 850 510(k) SUMMARY AVAILABLE FROM FDA
BETHESDA, MD 20814
DEVICE: SPIRAL RADIUS RODDING SYSTEM
UNITED STATES SURGICAL CORP. 510(k) NO: K000009(ABBREVIATED)
ATTN: LUIS NESPRIDO PHONE NO : 203-845-1552
150 GLOVER AVE. SE DECISION MADE: 10-MAR-00
NORWALK, CT 06856 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONOFILAMENT BIOSYN SUTURE
UNITED STATES SURGICAL CORP. 510(k) NO: K000037(TRADITIONAL)
ATTN: SETH A SCHULMAN PHONE NO : 203-845-4519
150 GLOVER AVE. SE DECISION MADE: 30-MAR-00
NORWALK, CT 06856 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E7512 PREMIE REM POLYHESIVE II PATIENT RETURN ELECTRODE
VALLEYLAB, INC. 510(k) NO: K994428(ABBREVIATED)
ATTN: ROBERT C MOORE JR PHONE NO : 800-265-8522
5920 LONGBOW DR. SE DECISION MADE: 07-MAR-00
P.O. BOX 9015 510(k) SUMMARY AVAILABLE FROM FDA
BOULDER, CO 80301
DEVICE: BRACHYVISION 6.0
VARIAN ASSOC., INC. 510(k) NO: K992762(TRADITIONAL)
ATTN: LINDA S NASH PHONE NO : 650-424-6990
3045 HANOVER STREET SE DECISION MADE: 09-MAR-00
PALO ALTO, CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEMAITRE IRRIGATION CATHETER
VASCUTECH, INC. 510(k) NO: K992933(TRADITIONAL)
ATTN: TRENT G KAMKE PHONE NO : 781-221-2266
164 MIDDLESEX TURNPIKE SE DECISION MADE: 08-MAR-00
BURLINGTON, MA 01803 510(k) STATEMENT
DEVICE: LEMAITRE VENOUS THROMBECTOMY CATHETER
VASCUTECH, INC. 510(k) NO: K992934(TRADITIONAL)
ATTN: TRENT G KAMKE PHONE NO : 781-221-2266
164 MIDDLESEX TURNPIKE SE DECISION MADE: 01-MAR-00
BURLINGTON, MA 01803 510(k) STATEMENT
DEVICE: VENUSA, LTD. EXTENSION SET WITH FILTER
VENUSA LTD. 510(k) NO: K994429(TRADITIONAL)
ATTN: ROSS MAGLADRY PHONE NO : 915-771-9112
31C BUTTERFIELD TRAIL SE DECISION MADE: 03-MAR-00
EL PASO, TX 79906 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OVES CERVICAL CAP
VEOS LTD. 510(k) NO: K993953(TRADITIONAL)
ATTN: PEGGY S DANNENBAUM PHONE NO :
273 MARKET SQUARE CT., #12 SE DECISION MADE: 21-MAR-00
LAKE FOREST, IL 60045 510(k) STATEMENT
DEVICE: VIDEOLABS MEDCAM PROPLUS VIDEO CAMERA AND INTEGRAL LIGHT SOURCE
VIDEOLABS INC. 510(k) NO: K000229(TRADITIONAL)
ATTN: FRANK B FREEDMAN PHONE NO : 612-593-5541
2530 PENNSYLVANIA AVENUE SE DECISION MADE: 21-MAR-00
SAINT LOUIS PARK, MN 55426 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSTATRAK 3000 SYSTEM WITH FLUOROTRAK MODULE, MODEL IT3000
VISUALIZATION TECHNOLOGY, INC. 510(k) NO: K994270(TRADITIONAL)
ATTN: NORMA LEMAY PHONE NO : 978-933-1000
200 RESEARCH DR. SE DECISION MADE: 09-MAR-00
WILMINGTON, MA 01887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100
VSM MEDTECH LTD. 510(k) NO: K994423(TRADITIONAL)
ATTN: HOWARD M HOLSTEIN PHONE NO : 202-637-5813
555 13TH STREET NW SE DECISION MADE: 28-MAR-00
WASHINGTON, DC 20004-1109 510(k) STATEMENT
DEVICE: WESCO BLANKET
WESCO, INC. 510(k) NO: K981093(TRADITIONAL)
ATTN: ARLEN C WEST PHONE NO : 309-699-7011
921 SUNSET DRIVE SE DECISION MADE: 28-MAR-00
EAST PEORIA, IL 61611 510(k) STATEMENT
DEVICE: DURASOFT 2 (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LE
WESLEY JESSEN CORP. 510(k) NO: K000439(TRADITIONAL)
ATTN: JOSEPH F FOOS PHONE NO : 847-294-3306
333 EAST HOWARD AVE. SE DECISION MADE: 20-MAR-00
DES PLAINES, IL 60018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROSOFT (PHEMFILCON) SOFT (HYDROPHILIC) CONTACT LENS
WESLEY JESSEN CORP. 510(k) NO: K994335(TRADITIONAL)
ATTN: JOSEPH F FOOS PHONE NO : 847-294-3306
333 EAST HOWARD AVE. SE DECISION MADE: 20-MAR-00
DES PLAINES, IL 60018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WILSON-COOK REUSABLE HOT BIOPSY FORCEPS
WILSON-COOK MEDICAL, INC. 510(k) NO: K000086(TRADITIONAL)
ATTN: MARGARET J POSNER PHONE NO : 336-744-0157
4900 BETHANIA STATION RD. SE DECISION MADE: 15-MAR-00
& 5951 GRASSY CREEK BLVD. 510(k) SUMMARY AVAILABLE FROM FDA
WINSTON-SALEM, NC 27105
DEVICE: CO2-OP-PNEU COMPUTER, WISAP #7050C, #7050CF, #7050CMF
WISAP GESELLSCHAFT FUR WISSENSCHAF510(k) NO: K992481(TRADITIONAL)
ATTN: H. SEMM PHONE NO : 49 0 8104/89080
RUDOLF-DIESEL-RING 20 SE DECISION MADE: 17-MAR-00
SAUERLACH, GERMANY D-82054 510(k) STATEMENT
DEVICE: THERME-PNEU COMPUTER, WISAP #7070C, #7070CF, #7070CM, #7070CMF
WISAP GESELLSCHAFT FUR WISSENSCHAF510(k) NO: K992513(TRADITIONAL)
ATTN: HORST SEMM PHONE NO : 490 810 4/8908-0
RUDOLF-DIESEL-RING 20 SE DECISION MADE: 17-MAR-00
SAUERLACH, GERMANY D-82054 510(k) STATEMENT
DEVICE: RELIEFBAND NST DEVICE, MODEL WB-2L, WB-6L, WB-RL
WOODSIDE BIOMEDICAL, INC. 510(k) NO: K994387(TRADITIONAL)
ATTN: CAROL PATTERSON PHONE NO : 949-462-0900
21911 ERIE LANE SE DECISION MADE: 16-MAR-00
LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES
XIMED MEDICAL/PROSURG. 510(k) NO: K994151(TRADITIONAL)
ATTN: LEE BUI PHONE NO : 408-945-4040
2195 TRADE ZONE BLVD. SE DECISION MADE: 01-MAR-00
SAN JOSE, CA 95131 510(k) STATEMENT
DEVICE: LOCATOR IMPLANT ANCHOR
ZEST ANCHORS, INC. 510(k) NO: K994257(TRADITIONAL)
ATTN: PAUL ZUEST PHONE NO : 760-743-7744
2061 WINERIDGE PL., SUITE 100 SE DECISION MADE: 17-MAR-00
ESCONDIDO, CA 92029 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZMR HIP SYSTEM-POROUS REVISION
ZIMMER, INC. 510(k) NO: K994286(TRADITIONAL)
ATTN: KAREN CAIN PHONE NO : 219-372-4219
P.O. BOX 708 SE DECISION MADE: 10-MAR-00
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 331
TOTAL WITH SUMMARIES 266
TOTAL WITH STATEMENTS 65
Updated 5/22/2000
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