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510(k)s Final Decisions Rendered for January 2001 |
SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE) 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD 01-JAN-2001 THROUGH 31-JAN-2001 DEVICE: A&D MEDICAL TM-2550/TM-2551/TM-2560 VITAL SENSOR MONITOR A & D ENGINEERING, INC. 510(k) NO: K002061(TRADITIONAL) ATTN: JERRY WANG PHONE NO : 408-263-5333 1555 MC CANDLESS DR. SE DECISION MADE: 19-JAN-01 MILPITAS, CA 95025 510(k) STATEMENT DEVICE: STERILE PISTON SYRINGE ABBOTT LABORATORIES 510(k) NO: K002717(TRADITIONAL) ATTN: THOMAS P SAMPONGA PHONE NO : 847-935-3715 D-389, AP-30 SE DECISION MADE: 08-JAN-01 200 ABBOTT PARK ROAD 510(k) STATEMENT ABBOTT PARK, IL 60064-6157 DEVICE: TE-2000 POWER TILT/POWER ELEVATING SEAT COMBINATION SYSTEM ACCELERATED REHAB DESIGNS, INC. 510(k) NO: K010011(TRADITIONAL) ATTN: RANDALL POTTER PHONE NO : 281-356-1950 32025 INDUSTRIAL PARK DR. SE DECISION MADE: 12-JAN-01 PINEHURST, TX 77362 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PATIENT DRAPE, SURGICAL ADVANCE MEDICAL DESIGNS, INC. 510(k) NO: K003670(TRADITIONAL) ATTN: BILL GILL PHONE NO : 770-422-3125 1241 ATLANTA INDUSTRIAL DR. SE DECISION MADE: 26-JAN-01 MARIETTA, GA 30066 510(k) STATEMENT DEVICE: KELO-COTE TOPICAL GEL ADVANCED BIO-TECHNOLOGIES, INC. 510(k) NO: K002488(TRADITIONAL) ATTN: DAVID BRYANT PHONE NO : 011 441 477549392 53 NEEDHAM DRIVE SE DECISION MADE: 05-JAN-01 SUITE 5, CW4 8FB 510(k) SUMMARY AVAILABLE FROM FDA CRANAGE, CHESHIRE, UNITED KINGDOM CW4 8FB DEVICE: RENEW NEUROSTIMULATION SYSTEM ADVANCED NEUROMODULATION SYSTEMS 510(k) NO: K000852(TRADITIONAL) ATTN: RASHMI MOZA PHONE NO : 972-309-8000 6501 WINDCREST DR., SE DECISION MADE: 19-JAN-01 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA PLANO, TX 75024 DEVICE: ADVANTAGE THC/COCAINE TEST ADVANTAGE DIAGNOSTICS CORP. 510(k) NO: K003708(TRADITIONAL) ATTN: JANIS FREESTONE PHONE NO : 650-569-3852 1201 DOUGLAS AVE. SE DECISION MADE: 22-JAN-01 REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: YASARGIL PERMANENT ANEURYSM CLIPS AESCULAP, INC. 510(k) NO: K003519(TRADITIONAL) ATTN: JOYCE THOMAS PHONE NO : 800-258-1946 944 MARCON BLVD SE DECISION MADE: 29-JAN-01 ALLENTOWN, PA 18109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 2010 PLUS HOLTER FOR WINDOWS AGILENT TECHNOLOGIES 510(k) NO: K003763(SPECIAL) ATTN: GRETEL LUMLEY PHONE NO : 805-604-0457 1201 "B" N. RICE AVE SE DECISION MADE: 05-JAN-01 OXNARD, CA 93030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AKTINA MEDICAL PHYSICS CORPORATION ACTIVE BREATHING COORDINATOR AKTINA MEDICAL PHYSICS CORP. 510(k) NO: K003330(TRADITIONAL) ATTN: JOAN ZACHAROPOULOS PHONE NO : 845-268-0101 360 NORTH ROUTE 9W SE DECISION MADE: 04-JAN-01 CONGERS, NY 10920 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MONARCH II IOL DELIVERY SYSTEM ALCON RESEARCH, LTD. 510(k) NO: K003768(ABBREVIATED) ATTN: SHERRI J LAKOTA PHONE NO : 817-568-6179 6201 SOUTH FREEWAY SE DECISION MADE: 05-JAN-01 FORT WORTH, TX 76134-2099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LENSOCLEAN MULTI-PURPOSE SOLUTION, MODEL 355ML ALPHA VISTA INC. 510(k) NO: K003031(TRADITIONAL) ATTN: HELMUT WEBER PHONE NO : 415-382-9146 42 DIGITAL DR., SUITE 12 SE DECISION MADE: 05-JAN-01 NOVATA, CA 94949 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FAMILY OF ALTUS MEDICAL COOLGLIDE AESTHETIC LASERS, MODELS I & I ALTUS MEDICAL 510(k) NO: K003202(TRADITIONAL) ATTN: MICHAEL LEVERNIER PHONE NO : 650-552-9700 821 COWAN RD. SE DECISION MADE: 10-JAN-01 BURLINGAME, CA 94010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLEXICAST AMERICAN DENT-ALL INC. 510(k) NO: K003509(TRADITIONAL) ATTN: VACHAKAN H KHOIE PHONE NO : 818-662-0618 5140 SAN FERNANDO ROAD SE DECISION MADE: 02-JAN-01 GLENDALE, CA 91204 510(k) STATEMENT DEVICE: ANGIODYNAMICS SOFT-VU SIZING ANGIOGRAPHIC CATHETER ANGIODYNAMICS, INC. 510(k) NO: K003901(SPECIAL) ATTN: TERI JUCKETT PHONE NO : 518-798-1215 603 QUEENSBURY AVE. SE DECISION MADE: 17-JAN-01 QUEENSBURY, NY 12804 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENCORE POWDER-FREE LATEX SURGICAL GLOVES, ORTHOPAEDIC WITH PROTE ANSELL HEALTHCARE PRODUCTS, INC. 510(k) NO: K003771(SPECIAL) ATTN: JAMES R CHATTERTON PHONE NO : 330-833-2811 1875 HARSH AVENUE, SE SE DECISION MADE: 16-JAN-01 MASSILLON, OH 44646 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: X-TENDA CUFF POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONT ANSELL PERRY 510(k) NO: K003895(SPECIAL) ATTN: JAMES R CHATTERTON PHONE NO : 330-833-2811 1875 HARSH AVENUE, S.E. SE DECISION MADE: 17-JAN-01 MASSILLON, OH 44646-7199 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEM APEX BIOTECHNOLOGY CORP. 510(k) NO: K002621(TRADITIONAL) ATTN: STEVEN CREES PHONE NO : 763-519-1664 3600 HOLLY LANE N. SE DECISION MADE: 22-JAN-01 SUITE 90 510(k) STATEMENT PLYMOUTH, MN 55447 DEVICE: GLUCOSMART BLOOD GLUCOSE MONITORING SYSTEM APEX BIOTECHNOLOGY CORP. 510(k) NO: K002624(TRADITIONAL) ATTN: STEVEN CREES PHONE NO : 763-519-1664 3600 HOLLY LANE N. SE DECISION MADE: 22-JAN-01 SUITE 90 510(k) STATEMENT PLYMOUTH, MN 55447 DEVICE: FLEXIBLE OCCLUSION SYSTEM APPLIED MEDICAL 510(k) NO: K002915(TRADITIONAL) ATTN: ANIL BHALANI PHONE NO : 949-713-8327 22872 AVENIDA EMPRESA SE DECISION MADE: 08-JAN-01 RANCHO SANTA MARGARITA, CA 92688 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACROTHERM AQUARIUS MEDICAL CORP. 510(k) NO: K003368(TRADITIONAL) ATTN: CHRISTINA M FLEMING PHONE NO : 480-991-1818 16047 NORTH 82ND ST. SE DECISION MADE: 19-JAN-01 SCOTTSDALE, AZ 85260 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIO-ABSORBABLE CORKSCREW MODEL AR-1920B ARTHREX, INC. 510(k) NO: K003227(TRADITIONAL) ATTN: VERNON BROWN PHONE NO : 941-643-5553 2885 SOUTH HORSESHOE DR. SE DECISION MADE: 08-JAN-01 NAPLES, FL 34104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASTRA TECH IMPLANTS - DENTAL SYSTEM ASTRA TECH, INC. 510(k) NO: K002513(TRADITIONAL) ATTN: NIKLAS LIDSKOG PHONE NO : 781-861-7707 430 BEDFORD STREET SE DECISION MADE: 04-JAN-01 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA LEXINGTON, MA 02420 DEVICE: 2-PIECE POST AND CORE FOR THE B.A.S.I.C. DENTAL IMPLANT SYSTEM BASIC DENTAL IMPLANT SYSTEMS, INC.510(k) NO: K001259(TRADITIONAL) ATTN: DAN BLACKLOCK PHONE NO : 505-881-1376 3321 COLUMBIA, N.E. SE DECISION MADE: 12-JAN-01 ALBUQUERQUE, NM 87107-2001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PENILE CONSTRICTOR RING BASIC SOLUTIONS, LLC 510(k) NO: K001859(TRADITIONAL) ATTN: JAY H GELLER PHONE NO : 310-449-1399 2425 W. OLYMPIC BOULEVARD SE DECISION MADE: 11-JAN-01 WEST TOWER, SUITE 4000 510(k) STATEMENT SANTA MONICA, CA 90404 DEVICE: BD PROBETEC ET MYCOBACTERIUM TUBERCULOSIS COMPLEX (CTB) CULTURE BD BECTON DICKINSON VACUTAINER SYS510(k) NO: K000884(TRADITIONAL) ATTN: COLLEEN ROHRBECK PHONE NO : 410-316-4988 7 LOVETON CIRCLE SE DECISION MADE: 19-JAN-01 SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION BIO-PLEXUS, INC. 510(k) NO: K003827(SPECIAL) ATTN: PAUL A TENTHOREY PHONE NO : 860-870-6112 129 RESERVOIR RD. SE DECISION MADE: 08-JAN-01 VERNON, CT 06066-5705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOEMG II AND BIOJVA BIO-RESEARCH ASSOCIATES, INC. 510(k) NO: K003176(TRADITIONAL) ATTN: JOHN C RADKE PHONE NO : 414-332-3003 4113 NORTH PORT WASHINGTON RD. SE DECISION MADE: 04-JAN-01 MILWAUKEE, WI 53212 510(k) STATEMENT DEVICE: EPI-DERM SILICONE GEL SHEETING BIODERMIS CORP. 510(k) NO: K003948(TRADITIONAL) ATTN: JEFF S SCHLEUING PHONE NO : 800-322-3729 3078 EAST SUNSET RD. SUITE #1 SE DECISION MADE: 29-JAN-01 LAS VEGAS, NV 89120 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TWILITE, TWILITE WHITE BIOLASE TECHNOLOGY, INC. 510(k) NO: K003385(TRADITIONAL) ATTN: IOANA M RIZOIU PHONE NO : 949-361-1200 981 CALLE AMANECER SE DECISION MADE: 25-JAN-01 SAN CLEMENTE, CA 92673 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOMET'S MINIMALLY CONSTRAINED ELBOW BIOMET, INC. 510(k) NO: K003253(TRADITIONAL) ATTN: SARA A BAILEY PHONE NO : 219-372-1568 AIRPORT INDUSTRIAL PARK SE DECISION MADE: 12-JAN-01 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: LACTOSORB SCREW ANCHOR BIOMET, INC. 510(k) NO: K003273(TRADITIONAL) ATTN: MARY VERSTYNEN PHONE NO : 219-267-6639 AIRPORT INDUSTRIAL PARK SE DECISION MADE: 11-JAN-01 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: MAXIM KNEE SYSTEM BIOMET, INC. 510(k) NO: K010027(SPECIAL) ATTN: DALENE T BINKLEY PHONE NO : 800-348-9500 56 EAST BELL DRIVE SE DECISION MADE: 12-JAN-01 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOSORBFX TACK AND BIOSORBPDX TACK BIOABSORBABLE FIXATION FASTEN BIONX IMPLANTS, INC. 510(k) NO: K003756(SPECIAL) ATTN: DAVID W ANDERSON PHONE NO : 215-643-5000 1777 SENTRY PKWY. WEST, SE DECISION MADE: 03-JAN-01 GWYNEDD HALL, SUITE 400 510(k) SUMMARY AVAILABLE FROM FDA BLUE BELL, PA 19422 DEVICE: CONTOUR LABRAL NAIL, MODEL 533520A BIONX IMPLANTS, INC. 510(k) NO: K003970(SPECIAL) ATTN: TUIJA ANNALA PHONE NO : 358 331 65600 HERMIANKATU 6-8 L SE DECISION MADE: 12-JAN-01 TAMPERE, FINLAND FIN-33720 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE BIOPLATE RESORBABLE BONE PLATING SYSTEM FOR CRANIOMAXILLOFAC BIOPLATE INC. 510(k) NO: K994060(TRADITIONAL) ATTN: ERIC V HOHENSTEIN PHONE NO : 323-549-9500 6911 MELROSE AVENUE SE DECISION MADE: 24-JAN-01 LOS ANGELES, CA 90038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE BIOPLATE REGID FIXATION BONE PLATING SYSTEM FOR CRANOMAXILLO BIOPLATE, INC. 510(k) NO: K002426(TRADITIONAL) ATTN: CAROL E JONES PHONE NO : 323-549-9500 6911 MELROSE AVE. SE DECISION MADE: 26-JAN-01 LOS ANGELES, CA 90038 510(k) STATEMENT DEVICE: BIOTEQUE VAGINAL DILATOR BIOTEQUE AMERICA, INC. 510(k) NO: K003380(TRADITIONAL) ATTN: DENIS DORSEY PHONE NO : 215-750-8071 340 EAST MAPLE AVE., #204-C SE DECISION MADE: 29-JAN-01 LANGHORNE, PA 19047 510(k) STATEMENT DEVICE: PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES BIOTRONIK, INC. 510(k) NO: K003072(TRADITIONAL) ATTN: JON BRUMBAUGH PHONE NO : 888-345-0374 6024 JEAN RD. SE DECISION MADE: 09-JAN-01 LAKE OSWEGO, OR 97035-5369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: A1-CS-SB Y-ADAPTER, MODEL 124 871 BIOTRONIK, INC. 510(k) NO: K003454(SPECIAL) ATTN: JON BURMBAUGH PHONE NO : 888-345-0374 6024 JEAN RD. SE DECISION MADE: 18-JAN-01 LAKE OSWEGO, OR 97035-5369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONTOUR POLARIS URETERAL STENT BOSTON SCIENTIFIC CORP. 510(k) NO: K010002(SPECIAL) ATTN: LINDA J VARROSO PHONE NO : 508-652-5192 ONE BOSTON SCIENTIFIC PLACE SE DECISION MADE: 22-JAN-01 NATICK, MA 01760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO FLUROTEX SURGICAL MESH BRIDGER BIOMED, INC. 510(k) NO: K003906(TRADITIONAL) ATTN: BRUCE G RUEFER PHONE NO : 406-586-7666 2430 NORTH 7TH AVE., SUITE 4 SE DECISION MADE: 26-JAN-01 BOZEMAN, MT 59715 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO FLUOROTEX II SURGICAL MESH BRIDGER BIOMED, INC. 510(k) NO: K003917(TRADITIONAL) ATTN: BRUCE G RUEFER PHONE NO : 406-586-7666 2430 NORTH 7TH AVE., SUITE 4 SE DECISION MADE: 26-JAN-01 BOZEMAN, MT 59715 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BARD ENDOCINCH SUTURING SYSTEM # 000452; 000454; 000595 C.R. BARD INC. 510(k) NO: K003956(TRADITIONAL) ATTN: BETH A ZIS PHONE NO : 978-262-4866 129 CONCORD ROAD, SE DECISION MADE: 05-JAN-01 BUILDING 3 510(k) SUMMARY AVAILABLE FROM FDA BILLERICA, MA 01821 DEVICE: BARD MEMOTHERM ENDOSCOPIC BILIARY STENT C.R. BARD, INC. 510(k) NO: K003186(TRADITIONAL) ATTN: BETH A ZIS PHONE NO : 978-262-4866 129 CONCORD RD. SE DECISION MADE: 09-JAN-01 BILLERICA, MA 01821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BARDEX LATEX-FREE TEMPERATURE-SENSING FOLEY CATHETER (UNCOATED); C.R. BARD, INC. 510(k) NO: K003289(ABBREVIATED) ATTN: GEORGE C ABERNATHY PHONE NO : 770-784-6454 8195 INDUSTRIAL BLVD. SE DECISION MADE: 05-JAN-01 COVINGTON, GA 30014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BARD LUMINEXX BILIARY STENT C.R. BARD, INC. 510(k) NO: K003793(SPECIAL) ATTN: CAROL VIERLING PHONE NO : 770-385-2347 13183 HARLAND DRIVE SE DECISION MADE: 05-JAN-01 COVINGTON, GA 30014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANALYTIC SPECTRAL METHOD OF ALTERNANS PROCESSING; CH 2000 CARDIA CAMBRIDGE HEART, INC. 510(k) NO: K003492(TRADITIONAL) ATTN: JOHN GREENBAUM PHONE NO : 954-680-2548 20310 SW 48TH ST. SE DECISION MADE: 18-JAN-01 FT. LAUDERDALE, FL 33332 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEEDLE BARN STICK STOPPER WITH SAFETY CAP, IN KIT WITH STERILE F CAMBRIDGE MARKETING, INC. 510(k) NO: K010038(TRADITIONAL) ATTN: JOSEPH B DUNN PHONE NO : 262-534-2787 P.O. 306 SE DECISION MADE: 24-JAN-01 813 ELA AVENUE 510(k) STATEMENT WATERFORD, WI 53185 DEVICE: DENLASER, MODEL 800 CAO GROUP, INC. 510(k) NO: K003541(TRADITIONAL) ATTN: TRACY S BEST PHONE NO : 801-256-9282 627 WEST SANDY PARKWAY SE DECISION MADE: 25-JAN-01 SANDY, UT 84070 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAVEX TEMPORARY CEMENT CAVEX HOLLAND B.V. 510(k) NO: K003791(TRADITIONAL) ATTN: RICHARD WOORTMAN PHONE NO : 31 23 5307763 2003 RW HAARLEM SE DECISION MADE: 23-JAN-01 PO BOX 852 510(k) STATEMENT HARMEN, NETHERLANDS DEVICE: CHASE CARDIOVASCULAR PATCH CHASE MEDICAL, INC. 510(k) NO: K003467(TRADITIONAL) ATTN: DAVE HERNON PHONE NO : 972-783-0644 1876 FIRMAN DR. SE DECISION MADE: 29-JAN-01 RICHARDSON, TX 75081 510(k) STATEMENT DEVICE: LIQUIDERM LIQUID ADHESIVE BANDAGE CLOSURE MEDICAL CORP. 510(k) NO: K002338(TRADITIONAL) ATTN: W. THOMAS STEPHENS PHONE NO : 919-876-7800 5250 GREENS DAIRY RD. SE DECISION MADE: 29-JAN-01 RALEIGH, NC 27616 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CODONICS NP-1660 SERIES MEDICAL PRINTERS, MODEL 1660 CODONICS, INC. 510(k) NO: K003481(TRADITIONAL) ATTN: GARY J ALLSEBROOK PHONE NO : 510-276-2648 16303 PANORAMIC WAY SE DECISION MADE: 19-JAN-01 SAN LEANDRO, CA 94578-1116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COLLAGEN PERIODONTAL MEMBRANE COLLAGEN MATRIX, INC. 510(k) NO: K003339(TRADITIONAL) ATTN: SHU-TUNG LI PHONE NO : 201-405-1477 509 COMMERCE STREET SE DECISION MADE: 08-JAN-01 FRANKLIN LAKES,, NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTRODEUCE DOUBLE LUMEN INTRODUCER COOK INCORPORATED 510(k) NO: K001985(TRADITIONAL) ATTN: APRIL LAVENDER PHONE NO : 812-339-2235 925 S. CURRY PIKE SE DECISION MADE: 25-JAN-01 P.O. BOX 489 510(k) SUMMARY AVAILABLE FROM FDA BLOOMINGTON, IN 47402 DEVICE: DOUBLE LUMEN URETHANE PICC LINE, MODEL UPICDS- COOK, INC. 510(k) NO: K010034(SPECIAL) ATTN: LISA WEBB PHONE NO : 812-339-2235 925 S. CURRY PIKE SE DECISION MADE: 24-JAN-01 BLOOMINGTON, IN 47401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRAPEASE PERMANENT VENA FILTER AND INTRODUCTION KIT, MODELS 466- CORDIS CORP. 510(k) NO: K003964(SPECIAL) ATTN: KAREN WILK PHONE NO : 908-412-7257 7 POWDERHORN DRIVE SE DECISION MADE: 19-JAN-01 WARREN, NJ 07059 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROWLER INFUSION CATHETERS WITH PRE-SHAPED TIPS CORDIS NEUROVASCULAR, INC. 510(k) NO: K003925(SPECIAL) ATTN: AMARILYS MACHADO PHONE NO : 305-512-6493 14000 N.W. 57TH CT. SE DECISION MADE: 08-JAN-01 MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COSMED QUARK COSMED S.R.L. 510(k) NO: K001174(TRADITIONAL) ATTN: ROBERT SCHIFF PHONE NO : 973-227-1830 1129 BLOOMFIELD AVENUE SE DECISION MADE: 11-JAN-01 WEST CALDWELL, NJ 07006 510(k) STATEMENT DEVICE: CARE PROVIDER STATION ADDITION OF WEIGHT SCALE CYBERCARE TECHNOLOGIES, INC. 510(k) NO: K003485(TRADITIONAL) ATTN: GORDON J PETERS PHONE NO : 770-352-9540 7840 ROSWELL RD., BLDG. 300 SE DECISION MADE: 11-JAN-01 SUITE 320 510(k) SUMMARY AVAILABLE FROM FDA ATLANTA, GA 30350-4889 DEVICE: STRATUS CS STAT FLUOROMETRIC ANALYZER BHCG TESTPAK,TEST SYSTEM, DADE BEHRING, INC. 510(k) NO: K003696(TRADITIONAL) ATTN: LAURENCE A POTTER PHONE NO : 302-631-0441 RT. 896, GLASCOW BLDG. 500 SE DECISION MADE: 25-JAN-01 NEWARK, DE 19714 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DRIED GRAM-POSITIVE MIC/COMBO PANELS DADE MICROSCAN, INC. 510(k) NO: K003619(TRADITIONAL) ATTN: CYNTHIA VAN DUKER PHONE NO : 916-374-3105 1584 ENTERPRISE BLVD. SE DECISION MADE: 09-JAN-01 WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,00102 DAVOL, INC. 510(k) NO: K003323(TRADITIONAL) ATTN: PAULA E BULGER PHONE NO : 401-463-7000 SUBSIDIARY OF C.R. BARD SE DECISION MADE: 22-JAN-01 100 SOCKANOSSETT CROSSROAD 510(k) SUMMARY AVAILABLE FROM FDA CRANSTON, RI 02920 DEVICE: RAPIDD HIGHSPEED DENTAL HANDPIECE DENTSPLY INTL. 510(k) NO: K003518(TRADITIONAL) ATTN: P. JEFFREY LEHN PHONE NO : 717-845-7511 570 WEST COLLEGE AVE SE DECISION MADE: 09-JAN-01 YORK, PA 17404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DYRACT CEM LCI COMPOMER DENTSPLY INTL. 510(k) NO: K003921(TRADITIONAL) ATTN: P. JEFFREY LEHN PHONE NO : 717-845-7511 570 WEST COLLEGE AVE SE DECISION MADE: 24-JAN-01 YORK, PA 17404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VA DENVER BIOMEDICALS, INC. 510(k) NO: K003451(SPECIAL) ATTN: BONNIE VIVIAN PHONE NO : 303-279-7500 14998 W. 6TH AVE., BLDG. E700 SE DECISION MADE: 02-JAN-01 GOLDEN, CO 80401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYMPHONY GRAFT DELIVERY SYSTEM DEPUY ACROMED 510(k) NO: K003286(TRADITIONAL) ATTN: FRANK MAAS PHONE NO : 508-828-3390 325 PARAMOUNT DR. SE DECISION MADE: 18-JAN-01 RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ISOLA CLOSED DUAL ROD CONNECTOR DEPUY ACROMED 510(k) NO: K003822(SPECIAL) ATTN: FRANK MAAS PHONE NO : 508-828-3390 325 PARAMOUNT DR. SE DECISION MADE: 08-JAN-01 RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COLLES C SERIES FRAME STERILE PACK DEPUY ORTHOPAEDICS, INC. 510(k) NO: K003397(TRADITIONAL) ATTN: MARCIA J ARENTZ PHONE NO : 219-371-4944 700 ORTHOPAEDIC DR. SE DECISION MADE: 29-JAN-01 P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0988 DEVICE: NARKOMED MRI-2, MODEL NM-MRI-2 DRAEGER MEDICAL, INC. 510(k) NO: K003579(SPECIAL) ATTN: MICHAEL A KELHART PHONE NO : 215-721-5400 3135 QUARRY RD. SE DECISION MADE: 22-JAN-01 TELFORD, PA 18969 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MIZAR, BASIS BE, SANDMAN DIGITAL EB NEURO, S.P.A. 510(k) NO: K003154(TRADITIONAL) ATTN: COLLEEN HITTLE PHONE NO : 317-849-1916 7992 CASTLEWAY DRIVE SE DECISION MADE: 05-JAN-01 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO EBI SPINELINK SYSTEM EBI, L.P. 510(k) NO: K003764(SPECIAL) ATTN: FREDERIC TESTA PHONE NO : 973-299-9022 100 INTERPACE PKWY. SE DECISION MADE: 02-JAN-01 PARSIPPANY, NJ 07054-1079 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EBI VUECATH SPINAL ENDOSCOPIC SYSTEM EBI, L.P. 510(k) NO: K003898(SPECIAL) ATTN: JON CAPAROTTA PHONE NO : 973-299-9022 100 INTERPACE PKWY. SE DECISION MADE: 04-JAN-01 PARSIPPANY, NJ 07054-1079 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM EBI, L.P. 510(k) NO: K010003(SPECIAL) ATTN: JON CAPAROTTA PHONE NO : 973-299-9022 100 INTERPACE PKWY. SE DECISION MADE: 31-JAN-01 PARSIPPANY, NJ 07054-1079 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIEW READING STATION ELECTROMED INTL., LTD. 510(k) NO: K003688(ABBREVIATED) ATTN: JEAN-LUC DES GROSEILLIERS PHONE NO : 450 491 2100 310 INDUSTRIAL BLVD. SE DECISION MADE: 22-JAN-01 ST-EUSTACHE, QUEBEC, CANADA J7R 5R510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FMP METAL/METAL ACETABULAR INSERT ENCORE ORTHOPEDICS, INC. 510(k) NO: K003250(TRADITIONAL) ATTN: DEBBIE DE LOS SANTOS PHONE NO : 512-832-9500 9800 METRIC BLVD. SE DECISION MADE: 25-JAN-01 AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROPOBE SERIES OF LASERS AND ACCESSORIES ENDO OPTIKS, INC. 510(k) NO: K003151(TRADITIONAL) ATTN: KEITH HERTZ PHONE NO : 732-530-6762 39 SYCAMORE AVE. SE DECISION MADE: 08-JAN-01 LITTLE SILVER, NJ 07739-1208 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: E.N.S.I. RETRACTABLE SAFETY SYRINGE ENSI-MED INTERNATIONAL PTY. LTD. 510(k) NO: K003348(TRADITIONAL) ATTN: NAP CURIE PHONE NO : 011 613 97824999 19-21 PENINSULA BLVD. SE DECISION MADE: 12-JAN-01 SEAFORD, VICTORIA, AUSTRALIA 3198 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: !NSURE FECAL OCCULT BLOOD TEST ENTERIX INC 510(k) NO: K002457(TRADITIONAL) ATTN: ROBERT C BRUCE PHONE NO : 207-781-4990 348 US ROUTE ONE SE DECISION MADE: 12-JAN-01 FALMOUTH,, ME 04105 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ERBE APC HANDLE AND APPLICATORS, MODEL 20132-043,20132-031,20132 ERBE USA, INC. 510(k) NO: K003462(ABBREVIATED) ATTN: JOHN TARTAL PHONE NO : 770-955-4400 2275 NORTHWEST PKWY., STE. 105 SE DECISION MADE: 04-JAN-01 MARIETTA, GA 30067 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAMMOTOME HAND HELD PROBE, MODEL MHH8 ETHICON ENDO-SURGERY, INC. 510(k) NO: K003297(TRADITIONAL) ATTN: DENNIS HAHN PHONE NO : 513-337-3134 4545 CREEK RD. SE DECISION MADE: 18-JAN-01 CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: "STIMATE N601 TENS" EVERYWAY MEDICAL INSTRUMENTS CO., 510(k) NO: K003487(TRADITIONAL) ATTN: DORA HSU YANG PHONE NO : 886 226 620038 2FL NO. 1-2 SE DECISION MADE: 24-JAN-01 TSAO TI WEI, SHEN KENG HSIANG 510(k) STATEMENT TAIPEI HSIEN,, CHINA (TAIWAN) DEVICE: SYMPULSE COMPUTER SYSTEM FOR FONAR MRI SCANNERS FONAR CORP. 510(k) NO: K003453(TRADITIONAL) ATTN: LUCIANO BONANNI PHONE NO : 631-694-2929 110 MARCUS DR., 102 MARCUS DR. SE DECISION MADE: 18-JAN-01 & 405 SMITH ST. 510(k) SUMMARY AVAILABLE FROM FDA MELVILLE, NY 11747 DEVICE: FRESENIUS OPTIFLUX 200A FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K003498(SPECIAL) ATTN: ARTHUR EILINSFELD PHONE NO : 781-402-9068 95 HAYDEN AVE. SE DECISION MADE: 04-JAN-01 TWO LEDGEMONT CENTER 510(k) SUMMARY AVAILABLE FROM FDA LEXINGTON, MA 02420-9192 DEVICE: FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT FUTURE DIAGNOSTICS B.V. 510(k) NO: K002638(TRADITIONAL) ATTN: DAVE D SMITH PHONE NO : 858-268-9232 4079 MT. BARNARD SE DECISION MADE: 17-JAN-01 SAN DIEGO, CA 92111 510(k) STATEMENT DEVICE: PATTERN RESIN GC AMERICA, INC. 510(k) NO: K003817(TRADITIONAL) ATTN: TERRY L JORITZ PHONE NO : 800-323-3105 3737 WEST 127TH ST. SE DECISION MADE: 16-JAN-01 ALSIP, IL 60803 510(k) STATEMENT DEVICE: MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM GE MEDICAL SYSTEM 510(k) NO: K003575(TRADITIONAL) ATTN: LARRY A KROGER PHONE NO : 262-544-3894 P.O. BOX 414, W-709 SE DECISION MADE: 17-JAN-01 MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIFFUSION TENSOR IMAGING OPTION GE MEDICAL SYSTEMS, INC. 510(k) NO: K003573(TRADITIONAL) ATTN: LARRY A KROGER PHONE NO : 262-544-3894 P.O. BOX 414, W-709 SE DECISION MADE: 23-JAN-01 MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIVID 7 WITH SONOPAC, MODEL FB0008XX GE MEDICAL SYSTEMS, INC. 510(k) NO: K003931(SPECIAL) ATTN: ALLEN SCHUH PHONE NO : 414-647-4385 P.O. BOX 414 SE DECISION MADE: 18-JAN-01 MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04 GEBAUER CO. 510(k) NO: K001624(TRADITIONAL) ATTN: DENISE E SPELLMAN PHONE NO : 216-271-5252 9410 ST. CATHERINE AVE. SE DECISION MADE: 25-JAN-01 CLEVELAND, OH 44104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CT PERFUSION 2 GENERAL ELECTRIC CO. 510(k) NO: K010042(TRADITIONAL) ATTN: LARRY A KROGER PHONE NO : 262-544-3894 P.O. BOX 414 SE DECISION MADE: 30-JAN-01 MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GENUA MENOPAUSE MONITOR TEST KIT GENUA 1944, INC. 510(k) NO: K002450(TRADITIONAL) ATTN: GARY LEHNUS PHONE NO : 908-362-5848 53 CEDAR LAKE RD. SE DECISION MADE: 12-JAN-01 BLAIRSTOWN, NJ 07825 510(k) STATEMENT DEVICE: GEON DIGITAL CLINICAL THERMOMETER GEON CORP. 510(k) NO: K003223(TRADITIONAL) ATTN: ALLEN REICH PHONE NO : 520-773-9488 900 N. SWITZER CANYOU DR. SE DECISION MADE: 12-JAN-01 SUITE 142 510(k) SUMMARY AVAILABLE FROM FDA FLAGGSTAFF, AZ 86001 DEVICE: CASTLE MODEL 233HC STEAM STERILIZER GETINGE/CASTLE, INC. 510(k) NO: K003441(SPECIAL) ATTN: FREDERICK R CATT PHONE NO : 716-272-5013 1777 EAST HENRIETTA RD. SE DECISION MADE: 02-JAN-01 ROCHESTER, NY 14623-3133 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GUTHRIE PRIME POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CON GUTHRIE MEDICARE PRODUCTS (NS) SDN510(k) NO: K003872(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 23-JAN-01 GREAT NECK, NY 11021 510(k) STATEMENT DEVICE: GUTHRIE SHIELD BLUE LATEX EXAMINATION GLOVES, POWDERED WITH PROT GUTHRIE MEDICARE PRODUCTS (NS) SDN510(k) NO: K010054(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 26-JAN-01 GREAT NECK, NY 11021 510(k) STATEMENT DEVICE: GUTHRIE SHIELD PLUS BLUE LATEX EXAMINATION GLOVES (POWDER-FREE) GUTHRIE MEDICARE PRODUCTS (NS) SDN510(k) NO: K010078(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 29-JAN-01 GREAT NECK, NY 11021 510(k) STATEMENT DEVICE: HARDYDISK NAFCILLIN, 1 MCG HARDY DIAGNOSTICS 510(k) NO: K003536(TRADITIONAL) ATTN: MELISSA M TRAYLOR PHONE NO : 805-346-2766 1430 WEST MCCOY LANE SE DECISION MADE: 12-JAN-01 SANTA MARIA, CA 93455 510(k) STATEMENT DEVICE: HARDYDISK RIFAMPIN, 5MCG HARDY DIAGNOSTICS 510(k) NO: K003537(TRADITIONAL) ATTN: MELISSA M TRAYLOR PHONE NO : 805-346-2766 1430 WEST MCCOY LANE SE DECISION MADE: 12-JAN-01 SANTA MARIA, CA 93455 510(k) STATEMENT DEVICE: HARDYDISK TRIMETHOPRIM 5MCG HARDY DIAGNOSTICS 510(k) NO: K003554(TRADITIONAL) ATTN: MELISSA M TRAYLOR PHONE NO : 805-346-2766 1430 WEST MCCOY LANE SE DECISION MADE: 19-JAN-01 SANTA MARIA, CA 93455 510(k) STATEMENT DEVICE: HARDYDISK AMOXICILLIN/CLAVULANIC ACID, 20/10MCG HARDY DIAGNOSTICS 510(k) NO: K003556(TRADITIONAL) ATTN: MELISSA M TRAYLOR PHONE NO : 805-346-2766 1430 WEST MCCOY LANE SE DECISION MADE: 17-JAN-01 SANTA MARIA, CA 93455 510(k) STATEMENT DEVICE: HARDYDISK TICARCILLIN/CLAVULANIC ACID, 85MCG HARDY DIAGNOSTICS 510(k) NO: K003686(TRADITIONAL) ATTN: MELISSA M TRAYLOR PHONE NO : 805-346-2766 1430 WEST MCCOY LANE SE DECISION MADE: 12-JAN-01 SANTA MARIA, CA 93455 510(k) STATEMENT DEVICE: HARDYDISK SULFISOXAZOLE HARDY DIAGNOSTICS 510(k) NO: K003690(TRADITIONAL) ATTN: MELISSA M TRAYLOR PHONE NO : 805-346-2766 1430 WEST MCCOY LANE SE DECISION MADE: 25-JAN-01 SANTA MARIA, CA 93455 510(k) STATEMENT DEVICE: HMS NEUROMUSCULAR STIMULATOR, MODEL HMS 3 HOME MEDICAL SERVICES 510(k) NO: K003231(TRADITIONAL) ATTN: C.A. TEKLINSKI PHONE NO : 858-621-5959 9393 ACTIVITY RD., SUITE F SE DECISION MADE: 12-JAN-01 SAN DIEGO, CA 92126 510(k) STATEMENT DEVICE: MS-ONE, MODEL MS-1 HOME WELLNESS WEST 510(k) NO: K003258(TRADITIONAL) ATTN: C.A. TEKLINSKI PHONE NO : 858-621-5959 9393 ACTIVITY ROAD SE DECISION MADE: 12-JAN-01 SUITE F 510(k) STATEMENT SAN DIEGO, CA 92126 DEVICE: HORIZONS ERCP CANNULA HORIZONS INTL. CORP. 510(k) NO: K002235(TRADITIONAL) ATTN: RAFIC SALEH PHONE NO : 787-997-1000 200 POLITECNICA STREET SE DECISION MADE: 23-JAN-01 VILLAS UNIV. PO BOX 250435 510(k) STATEMENT AGUADILLA, PR 00604 DEVICE: HORIZONS PAPILLOTOME HORIZONS INTL. CORP. 510(k) NO: K002236(TRADITIONAL) ATTN: RAFIC SALEH PHONE NO : 787-997-1000 200 POLITECNICA STREET SE DECISION MADE: 23-JAN-01 VILLAS UNIV. PO BOX 250435 510(k) STATEMENT AGUADILLA, PR 00604 DEVICE: HOFFMANN II EXTERNAL FIXATION SYSTEM 90 DEGREE POST HOWMEDICA OSTEONICS CORP. 510(k) NO: K003848(SPECIAL) ATTN: KAREN ARIEMMA PHONE NO : 201-760-8187 59 ROUTE 17 SE DECISION MADE: 11-JAN-01 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MRI LINE MARKER I.Z.I. CORP. 510(k) NO: K003736(TRADITIONAL) ATTN: HELEN ZINREICH PHONE NO : 410-594-9403 2624 LORD BALTIMORE DR., SE DECISION MADE: 18-JAN-01 SUITE K 510(k) STATEMENT BALTIMORE, MD 21244 DEVICE: TAXOL ADMINISTRATION SET ICU MEDICAL, INC. 510(k) NO: K003513(TRADITIONAL) ATTN: SALVADORE F PALOMARES PHONE NO : 949-366-2183 951 CALLE AMANECER SE DECISION MADE: 11-JAN-01 SAN CLEMENTE, CA 92673 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACTIVE ARRAY CATHETER, MODEL CS-2000 IMAGE-GUIDED NEUROLOGICS, INC. 510(k) NO: K001097(TRADITIONAL) ATTN: DAVID M LEE PHONE NO : 321-757-8990 2290 EAU GALLIE BLVD. SE DECISION MADE: 18-JAN-01 MELBOURNE, FL 32935 510(k) STATEMENT DEVICE: IMPLEX CONTINUUM KNEE SYSTEM-PATELLAR COMPONENTS, MODEL 04-XX-YY IMPLEX CORP. 510(k) NO: K004013(SPECIAL) ATTN: JOHN SCHALAGO PHONE NO : 201-818-1800 80 COMMERCE DR. SE DECISION MADE: 25-JAN-01 ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUANTA LITE CENTROMERE (CENP-A & CENP-B) ELISA INOVA DIAGNOSTICS, INC. 510(k) NO: K003959(TRADITIONAL) ATTN: BRY C MYERS PHONE NO : 858-586-9900 10180 SCRIPPS RANCH BLVD. SE DECISION MADE: 22-JAN-01 SAN DIEGO, CA 92131-1234 510(k) STATEMENT DEVICE: GLUTARTEST 1 REAGENT STRIP INTEGRATED BIOMEDICAL TECHNOLOGY, 510(k) NO: K002011(TRADITIONAL) ATTN: WEN H WU PHONE NO : 219-264-0025 2931 MOOSE TRAIL SE DECISION MADE: 22-JAN-01 ELKHART, IN 46514 510(k) STATEMENT DEVICE: GUARDED NEEDLE 2000 INTERNATIONAL MEDICAL DEVICE PARTN510(k) NO: K003406(TRADITIONAL) ATTN: JAMES R GREENWOOD PHONE NO : 702-450-0425 6801 IRIS CIRCLE SE DECISION MADE: 12-JAN-01 LOS ANGELES, CA 90068-2715 510(k) STATEMENT DEVICE: INTERGARD KNITTED ULTRA THIN AND INTERGARD KNITTED COLLAGEN COAT INTERVASCULAR, INC. 510(k) NO: K990800(TRADITIONAL) ATTN: JAMES S MILLER PHONE NO : 727-539-0833 16331 BAY VISTA DR. SE DECISION MADE: 08-JAN-01 CLEARWATER, FL 33760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS INTRATHERAPEUTICS, INC. 510(k) NO: K003997(SPECIAL) ATTN: AMY PETERSON PHONE NO : 612-697-2076 651 CAMPUS DR. SE DECISION MADE: 24-JAN-01 ST. PAUL, MN 55112-3495 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYALURONIDASE REAGENT, MODEL CAT#2212 INVITROCARE, INC. 510(k) NO: K003751(TRADITIONAL) ATTN: ROBERT E LOVINS PHONE NO : 858-452-1986 11408 SORRENTO VALLEY RD. SE DECISION MADE: 17-JAN-01 SUITE 202 510(k) STATEMENT SAN DIEGO, CA 92121 DEVICE: COMPLETE HUMAN TUBAL FLUID (HTF) WITH SERUM SUBSTITUTE SUPPLEMEN IRVINE SCIENTIFIC SALES CO., INC. 510(k) NO: K003278(TRADITIONAL) ATTN: WENDELL LEE PHONE NO : 949-437-5706 2511 DAIMLER ST. SE DECISION MADE: 17-JAN-01 SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYSTEMP.DESENSITIZER (VIVADENT.DESENSITIZER) IVOCLAR NORTH AMERICA, INC. 510(k) NO: K003407(TRADITIONAL) ATTN: ANDY GULATI PHONE NO : 716-691-0010 175 PINEVIEW DR. SE DECISION MADE: 26-JAN-01 AMHERST, NY 14228 510(k) STATEMENT DEVICE: DIRECT BILIRUBIN JAS DIAGNOSTIC, INC. 510(k) NO: K003693(TRADITIONAL) ATTN: DAVID JOHNSON PHONE NO : 305-418-2320 7220 NW 58TH ST. SE DECISION MADE: 29-JAN-01 MIAMI, FL 33166 510(k) STATEMENT DEVICE: BIO HERADOR SG, BIO HEADER GG, HERADOR S, BIO HERADOR N, HERABON JELENKO CO. 510(k) NO: K003603(TRADITIONAL) ATTN: RAPHAEL JUDKINS PHONE NO : 800-431-1785 99 BUSINESS PARK DRIVE SE DECISION MADE: 10-JAN-01 ARMONK, NY 10504 510(k) STATEMENT DEVICE: AVANTE CURELIGHT JENERIC/PENTRON, INC. 510(k) NO: K003683(TRADITIONAL) ATTN: ANNMARIE TENERO PHONE NO : 203-265-7397 53 NORTH PLAINS INDUSTRIAL RD. SE DECISION MADE: 11-JAN-01 P.O. BOX 724 510(k) SUMMARY AVAILABLE FROM FDA WALLINGFORD, CT 06492-0724 DEVICE: V/X ASPHERIC TORIC MULTIFOCAL (POLYMACON) SOFT (HYDROPHILIC) LEN JOE B. GOLDBERG, O.D. 510(k) NO: K003042(TRADITIONAL) ATTN: JOE B GOLDBERG PHONE NO : 757-425-3566 5500-B DAWSON ROAD SE DECISION MADE: 22-JAN-01 VIRGINIA BEACH, VA 23451 510(k) STATEMENT DEVICE: TRAK BACK II JOMED, INC. 510(k) NO: K003938(SPECIAL) ATTN: CHRISTINA KICHULA PHONE NO : 301-998-6151 1700 ROCKVILLE PIKE SE DECISION MADE: 18-JAN-01 SUITE 400 510(k) SUMMARY AVAILABLE FROM FDA ROCKVILLE, MD 20852 DEVICE: MOLINA ORBITAL MALAR DISTRACTOR KLS-MARTIN L.P. 510(k) NO: K003883(TRADITIONAL) ATTN: ART WARD PHONE NO : 813-645-2855 11239-1 ST. JOHN'S IND. PKWY. SE DECISION MADE: 23-JAN-01 SOUTH 510(k) SUMMARY AVAILABLE FROM FDA JACKSONVILLE, FL 32246 DEVICE: THE LIFECORE STAGE-1 SINGLE STAGE RBM DENTAL IMPLANT SYSTEM LIFECORE BIOMEDICAL, INC. 510(k) NO: K003226(TRADITIONAL) ATTN: CAROLYN ANDERSON PHONE NO : 952-386-6324 3515 LYMAN BLVD. SE DECISION MADE: 12-JAN-01 CHASKA, MN 55318 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MADA WHEELCHAIRS MADA MEDICAL PRODUCTS, INC. 510(k) NO: K003862(TRADITIONAL) ATTN: JEFFREY W ADAM PHONE NO : 201-460-0454 625 WASHINGTON AVE SE DECISION MADE: 12-JAN-01 CARLSTADT, NJ 07072 510(k) STATEMENT DEVICE: TEMPERATURE FUNCTION, MODEL 9500 MULTIGAS MONITOR MAGNETIC RESONANCE EQUIPMENT CORP.510(k) NO: K003982(TRADITIONAL) ATTN: G. RONALD MORRIS PHONE NO : 516-243-3565 6 WASHINGTON AVE. SE DECISION MADE: 26-JAN-01 BAY SHORE, NY 11706 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDCOMP Z-CATH MEDICAL COMPONENTS, INC. 510(k) NO: K003682(TRADITIONAL) ATTN: JEANNE M CUSH PHONE NO : 215-256-4201 1499 DELP DR. SE DECISION MADE: 26-JAN-01 HARLEYSVILLE, PA 19438 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDICAL DEPOT-WHEELCHAIRS, MODEL SENTRA,ASTAIRE AND VIPER MEDICAL DEPOT, INC. 510(k) NO: K003783(TRADITIONAL) ATTN: ART WARD PHONE NO : 813-645-2855 3234 ELLA LANE SE DECISION MADE: 12-JAN-01 NEW PORT RICHEY, FL 34655 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERTEX SYSTEM MEDICAL POSITIONING, INC. 510(k) NO: K002822(TRADITIONAL) ATTN: CAROL PATTERSON PHONE NO : 949-462-0900 21911 ERIE LANE SE DECISION MADE: 31-JAN-01 LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDLINE STERILIZATION WRAP MEDLINE INDUSTRIES, INC. 510(k) NO: K002968(TRADITIONAL) ATTN: LARA N SIMMONS PHONE NO : 847-949-2639 ONE MEDLINE PL. SE DECISION MADE: 23-JAN-01 MUNDELEIN, IL 60060-4486 510(k) STATEMENT DEVICE: MEDLINE STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEI MEDLINE INDUSTRIES, INC. 510(k) NO: K003055(TRADITIONAL) ATTN: LARA N SIMMONS PHONE NO : 847-949-2639 ONE MEDLINE PL. SE DECISION MADE: 26-JAN-01 MUNDELEIN, IL 60060-4486 510(k) STATEMENT DEVICE: INSTACCULT MEDTEK DIAGNOSTICS, LLC 510(k) NO: K002930(TRADITIONAL) ATTN: LIANE F GOSSET PHONE NO : 800-469-5395 PO BOX 14125 SE DECISION MADE: 22-JAN-01 RESEARCH TRIANGLE PARK, NC 27709-4510(k) STATEMENT DEVICE: PROFILE-ER MEDTOX DIAGNOSTICS, INC. 510(k) NO: K002331(TRADITIONAL) ATTN: MICHAEL TURANCHIK PHONE NO : 336-226-6311 1238 ANTHONY RD. SE DECISION MADE: 17-JAN-01 BURLINGTON, NC 27215 510(k) STATEMENT DEVICE: LIFEPAK 12DEFIBERLLATOR/MONITOR SERIES MEDTRONIC PHYSIO-CONTROL CORP. 510(k) NO: K002445(TRADITIONAL) ATTN: BOB ZITO PHONE NO : 425-867-4444 11811 WILLOWS RD., N.E. SE DECISION MADE: 31-JAN-01 REDMOND, WA 98073 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K003928(SPECIAL) ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PL. SE DECISION MADE: 17-JAN-01 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUROFILM NP METALOR DENTAL USA CORP. 510(k) NO: K003387(TRADITIONAL) ATTN: KENNETH A PUTNEY PHONE NO : 508-695-8143 255 JOHN L. DIETSCH BLVD. SE DECISION MADE: 09-JAN-01 NORTH ATTLEBOROUGH, MA 02761 510(k) STATEMENT DEVICE: VENODYNE DVT ADVANTAGE MODEL 610 MICROTEK MEDICAL, INC. 510(k) NO: K001802(TRADITIONAL) ATTN: THOMAS BONNER PHONE NO : 800-844-0988 512 LEHMBERG RD SE DECISION MADE: 09-JAN-01 COLUMBUS, MS 39702 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICRUS MICROCOIL DELIVERY SYSTEM, MDS03 MICRUS CORP. 510(k) NO: K002056(TRADITIONAL) ATTN: TOM HOLDYCH PHONE NO : 650-969-7000 495 CLYDE AVENUE SE DECISION MADE: 11-JAN-01 MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MPS ACACIA PAIN KIT MPS ACACIA 510(k) NO: K003476(TRADITIONAL) ATTN: FERGIE F FERGUSON PHONE NO : 714-257-0470 499 NIBUS ST., SUITE E SE DECISION MADE: 12-JAN-01 BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NC-STAT NEUROMETRIX, INC. 510(k) NO: K003508(TRADITIONAL) ATTN: JAMES R VEALE PHONE NO : 508-643-0434 49 PLAIN ST. SE DECISION MADE: 17-JAN-01 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE NITRILE EXAM GLOVE, LAVENDER/PURPLE NING BO YUJIANG RUBBER & PLASTIC C510(k) NO: K003563(TRADITIONAL) ATTN: JANNA P TUCKER PHONE NO : 775-342-2612 1998 AVENUE DE LA D'EMERALD SE DECISION MADE: 02-JAN-01 SPARKS, NV 89434 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APPALEAD GW+03XXXXXXR SERIES NIPRO MEDICAL CORP. 510(k) NO: K003394(ABBREVIATED) ATTN: CARY GOLDSMITH PHONE NO : 305-599-7174 3150 NW 107 AVE.. SE DECISION MADE: 30-JAN-01 MIAMI, FL 33172 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DR180+OXY NORTHEAST MONITORING, INC. 510(k) NO: K004007(SPECIAL) ATTN: RODNEY L CAMBRE PHONE NO : 978-440-8438 730 BOSTON POST RD., SUITE 23 SE DECISION MADE: 25-JAN-01 SUDBURY, MA 01776 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MULTITRACK ANGIOGRAPHIC CATHETER NUMED, INC. 510(k) NO: K003902(SPECIAL) ATTN: NICHELLE R LAFLESH PHONE NO : 315-328-4491 P.O BOX 129 SE DECISION MADE: 11-JAN-01 NICHOLVILLE, NY 12965 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUMED GHOST II PTA CATHETERS NUMED, INC. 510(k) NO: K003972(SPECIAL) ATTN: NICHELL LAFLESH PHONE NO : 315-328-4491 2880 MAIN ST. SE DECISION MADE: 11-JAN-01 HOPKINTON, NY 12965 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIFEMATE HEMOFILTRATION SYSTEM NXSTAGE MEDICAL, INC. 510(k) NO: K001283(TRADITIONAL) ATTN: JEFFREY BURBANK PHONE NO : 978-863-4555 3 HIGHWOOD DRIVE SE DECISION MADE: 17-JAN-01 TEWKSBURY, MA 01876 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OCULAR SCIENCES, INC. BIOMEDICS 52 (OCUFILCON D) UV BLOCKING DAI OCULAR SCIENCES, INC. 510(k) NO: K003136(TRADITIONAL) ATTN: RICHARD E LIPPMAN PHONE NO : 301-770-9590 12300 TWINBROOK PARKWAY SE DECISION MADE: 06-JAN-01 SUITE 625 510(k) SUMMARY AVAILABLE FROM FDA ROCKVILLE, MD 20852 DEVICE: LF-DP GASTROINTESTINAL AND SIGMOID FIBERSCOPE, ACCESSORIES AND A OLYMPUS OPTICAL CO., LTD. 510(k) NO: K002231(TRADITIONAL) ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688 TWO CORPORATE CENTER DRIVE SE DECISION MADE: 30-JAN-01 MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I ORASURE TECHNOLOGIES, INC. 510(k) NO: K002375(TRADITIONAL) ATTN: R. SAM NIEDBALA PHONE NO : 610-882-1820 1745 EATON AVE SE DECISION MADE: 26-JAN-01 BETHLEHEM, PA 18018-1799 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROSTREAM EXTERNAL BATTERY CHARGER ORIDION MEDICAL 1987 LTD. 510(k) NO: K002163(TRADITIONAL) ATTN: SANFORD BROWN PHONE NO : 972 258 99115 7 HAMARPE ST. P.O.B. 45025 SE DECISION MADE: 11-JAN-01 HAR HOTZVIM INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA JERUSALEM, ISRAEL 91450 DEVICE: TRIAD II MODULAR TOTAL HIP SYSTEM OSTEOIMPLANT TECHNOLOGY, INC. 510(k) NO: K003199(TRADITIONAL) ATTN: SAM SON PHONE NO : 410-785-0700 11201 PEPPER RD. SE DECISION MADE: 10-JAN-01 HUNT VALLEY, MD 21031-1201 510(k) STATEMENT DEVICE: OTI CERAMIC FEMORAL HEAD SYSTEM OSTEOIMPLANT TECHNOLOGY, INC. 510(k) NO: K003316(TRADITIONAL) ATTN: SAM SON PHONE NO : 410-785-0700 11201 PEPPER RD. SE DECISION MADE: 19-JAN-01 HUNT VALLEY, MD 21031-1201 510(k) STATEMENT DEVICE: VERTEBRAL BODY REPLACEMENT OSTEOTECH, INC. 510(k) NO: K003155(TRADITIONAL) ATTN: KIM THURMAN PHONE NO : 732-544-6231 51 JAMES WAY SE DECISION MADE: 04-JAN-01 EATONTOWN, NJ 07724 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PALOMAR CLEAR LIGHT ND: YAG LASER SYSTEM PALOMAR MEDICAL TECHNOLOGIES, INC.510(k) NO: K003460(TRADITIONAL) ATTN: MARCY MOORE PHONE NO : 919-363-2432 131 KELEKENT LANE SE DECISION MADE: 25-JAN-01 CARY, NC 27511 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PORTABLE BREAST COMPRESSION DEVICE PEM TECHNOLOGIES 510(k) NO: K003775(TRADITIONAL) ATTN: T. WHIT ATHEY PHONE NO : 301-770-9590 12300 TWINBROOK PARKWAY SE DECISION MADE: 12-JAN-01 SUITE 625 510(k) SUMMARY AVAILABLE FROM FDA BOCKVILLE, MD 20852 DEVICE: PENTAFERTE SINGLE USE SYRINGES, MODEL SIZE=VARIOUS SIZES PENTAFERTE S.R.L. 510(k) NO: K002381(TRADITIONAL) ATTN: VITTORIO SERVIDORI PHONE NO : 398 612 569945 ZONA INDUSTRIALE SE DECISION MADE: 11-JAN-01 CAMPLI, TERAMO, ITALY 64012 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OUTBACK CATHETER PERCLOSE, INC. 510(k) NO: K001577(TRADITIONAL) ATTN: DAUN S PUTNAM PHONE NO : 650-474-3135 400 SAGINAW DRIVE SE DECISION MADE: 11-JAN-01 REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHILIPS EASY VISION FAMILY WORKSTATION OPTION MR QUANTITATIVE FL PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K003459(TRADITIONAL) ATTN: PETER ALTMAN PHONE NO : 203-926-7031 710 BRIDGEPORT AVE. SE DECISION MADE: 22-JAN-01 SHELTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 260 CORVUS PIE MEDICAL 510(k) NO: K003292(TRADITIONAL) ATTN: COLLEEN J HITTLE PHONE NO : 317-849-1916 SE DECISION MADE: 05-JAN-01 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHLEBOPUMP, MODEL 1000 PREVENT PRODUCTS, INC. 510(k) NO: K003284(TRADITIONAL) ATTN: CAROL A GARCIA PHONE NO : 651-457-4385 1167 OTTAWA AVE. SE DECISION MADE: 17-JAN-01 WEST ST. PAUL, MN 55118 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATOR PROPPER MFG. CO., INC. 510(k) NO: K991618(TRADITIONAL) ATTN: JOHN D DYCKMAN PHONE NO : 718-392-6650 36-04 SKILLMAN AVE. SE DECISION MADE: 24-JAN-01 LONG ISLAND CITY, NY 11101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES PURNABINA SDN BHD 510(k) NO: K003904(TRADITIONAL) ATTN: LIEW YOON FONG PHONE NO : 607 787 9128 PLO 5 JLN. MAHSURI 1, SE DECISION MADE: 24-JAN-01 KAWASAN PERINDUSTRAIN KLUANG 510(k) STATEMENT KLUANG, JAHOR, MALAYSIA 86007 DEVICE: Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503 QUINTON INSTRUMENT CO. 510(k) NO: K003576(ABBREVIATED) ATTN: DAVID HIMES PHONE NO : 425-402-2484 3303 MONTE VILLA PKWY. SE DECISION MADE: 25-JAN-01 BOTHELL, WA 98021-8906 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CBC-4K HEMATOLOGY CONTROL R & D SYSTEMS, INC. 510(k) NO: K003874(SPECIAL) ATTN: KENNETH EDDS PHONE NO : 612-379-2956 614 MCKINLEY PL., N.E. SE DECISION MADE: 12-JAN-01 MINNEAPOLIS, MN 55413 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CD-CAL PLUS CALIBRATOR R & D SYSTEMS, INC. 510(k) NO: K003991(SPECIAL) ATTN: KENNETH T EDDS PHONE NO : 612-379-2965 614 MCKINLEY PL., N.E. SE DECISION MADE: 16-JAN-01 MINNEAPOLIS, MN 55413 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RADIANALYZER, MODEL 12710 RADI MEDICAL SYSTEMS AB 510(k) NO: K002067(TRADITIONAL) ATTN: MATS GRANLUND PHONE NO : 46 18 161000 PALMBLADSGATAN 10 SE DECISION MADE: 11-JAN-01 UPPSALA, SWEDEN S-754 50 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TROCARS "TROTEC" WITH AUTOMATIC PROTECTIVE MECHANISM RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K003164(TRADITIONAL) ATTN: ROBERT L CASARSA PHONE NO : 847-913-1113 353 CORPORATE WOODS PKWY. SE DECISION MADE: 08-JAN-01 VERNON HILLS, IL 60061 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RITA STARBURST XLI ELECTROSURGICAL DEVICE RITA MEDICAL SYSTEMS 510(k) NO: K010060(TRADITIONAL) ATTN: ERIN MAZZONE PHONE NO : 650-314-3439 967 NORTH SHORELINE BLVD. SE DECISION MADE: 23-JAN-01 MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALGINATE IMPRESSION MATERIAL RITE-DENT MANUFACTURING CORPORATIO510(k) NO: K003426(TRADITIONAL) ATTN: CESAR E VELIZ PHONE NO : 305-693-8626 1056 EAST 33RD ST. SE DECISION MADE: 23-JAN-01 HIALEAH, FL 33013-3526 510(k) STATEMENT DEVICE: ZINC PHOSPHATE CEMENT RITE-DENT MANUFACTURING CORPORATIO510(k) NO: K003427(TRADITIONAL) ATTN: CESAR E VELIZ PHONE NO : 305-693-8626 1056 EAST 33RD ST. SE DECISION MADE: 24-JAN-01 HIALEAH, FL 33013-3526 510(k) STATEMENT DEVICE: LARYNGEAL SURFACE ELECTRODE-ENDOTRACHEAL TUBE, M-500-ET, LSE-ET RLN SYSTEMS, INC. 510(k) NO: K003745(TRADITIONAL) ATTN: J. LEE REA PHONE NO : 573-635-0469 2019 HONEYSUCKLE LN. SE DECISION MADE: 16-JAN-01 JEFFERSON CITY, MO 65109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECSYS DHEA-S ROCHE DIAGNOSTICS CORP. 510(k) NO: K003174(TRADITIONAL) ATTN: KAY A TAYLOR PHONE NO : 317-576-3544 9115 HAGUE RD. SE DECISION MADE: 17-JAN-01 INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECSYS FSH CALSET II ROCHE DIAGNOSTICS CORP. 510(k) NO: K003409(ABBREVIATED) ATTN: KAY A TAYLOR PHONE NO : 317-576-3544 9115 HAGUE ROAD SE DECISION MADE: 26-JAN-01 P.O. BOX 50457 510(k) SUMMARY AVAILABLE FROM FDA INDIANAPOLIS, IN 46250-0457 DEVICE: ELECSYS HCG STAT CLASET II ROCHE DIAGNOSTICS CORP. 510(k) NO: K003941(TRADITIONAL) ATTN: KAY A TAYLOR PHONE NO : 317-576-3544 9115 HAGUE RD. SE DECISION MADE: 25-JAN-01 INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CA 125 II CALCHECK ROCHE DIAGNOSTICS CORP. 510(k) NO: K003967(SPECIAL) ATTN: KAY A TAYLOR PHONE NO : 317-576-3544 9115 HAGUE RD. SE DECISION MADE: 12-JAN-01 INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECSYS CA 125 II CALSET ROCHE DIAGNOSTICS CORP. 510(k) NO: K003969(SPECIAL) ATTN: KAY A TAYLOR PHONE NO : 800-428-5074 9115 HAGUE RD. SE DECISION MADE: 12-JAN-01 INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NETRA WORKSTATION AND NETRAMD SOFTWARE SCIMAGE, INC. 510(k) NO: K003484(TRADITIONAL) ATTN: MICHAEL PETER PHONE NO : 650-694-4858 4916 EL CAMINO REAL, SUITE 200 SE DECISION MADE: 19-JAN-01 LOS ALTOS, CA 94022 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING SELTOM PACIFIC SDN. BHD. 510(k) NO: K003934(TRADITIONAL) ATTN: S. SEAGARAN PHONE NO : 603 735 6010 LOT 25, JALAN PJS 7/17 SE DECISION MADE: 26-JAN-01 SUNWAY INDUSTRIAL PARK 510(k) STATEMENT PETALING JAYA, SELANGOR, MALAYSIA 46150 DEVICE: SHANGHAI CHINA STAR CORP POWDERED BLUE NITRILE PATIENT EXAMINATI SHANGHAI CHINASTAR CORP. 510(k) NO: K003675(TRADITIONAL) ATTN: LEE HUNG TE CHE PHONE NO : 886 227 136677 NO. 283, CHE XING ROAD SE DECISION MADE: 09-JAN-01 CHE DUN ZHEN,SONG JIANG COUNTY 510(k) SUMMARY AVAILABLE FROM FDA SHANGHAI, CHINA DEVICE: CARDIO MONITOR CENTER VISION; MODEL S-CV7-00 SHL TELEMEDICINE INTERNATIONAL LTD510(k) NO: K003392(TRADITIONAL) ATTN: ALROY IRIT PHONE NO : 972 356 12212 90 YIGAL ALON STREET SE DECISION MADE: 25-JAN-01 TEL AVIV, ISRAEL 67891 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAGNETOM RHAPSODY SYSTEM SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K003628(ABBREVIATED) ATTN: JAMIE YIEH PHONE NO : 732-321-4625 186 WOOD AVENUE SOUTH SE DECISION MADE: 23-JAN-01 ISELIN, NJ 08830 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QPS (QUANTITATIVE PERFUSION SPECT), QGS (QUANTITATIVE GATED SPEC SMV AMERICA 510(k) NO: K003358(TRADITIONAL) ATTN: PAULA MCLEAN PHONE NO : 800-664-0844 8380 DARROW RD. SE DECISION MADE: 19-JAN-01 TWINSBURG, OH 44087 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOFRADIM PARIETEX SURGICAL MESHES SOFRADIM PRODUCTION 510(k) NO: K003990(SPECIAL) ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 24-JAN-01 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PARSFIX CABLE-SCREW SYSTEM SPINAL CONCEPTS, INC. 510(k) NO: K003351(TRADITIONAL) ATTN: DAVID M HOOPER PHONE NO : 512-918-2700 12012 TECHNOLOGY BLVD., #100 SE DECISION MADE: 24-JAN-01 AUSTIN, TX 78727 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PC FLOW + SPIROMETRICS MEDICAL EQUIPMENT CO.510(k) NO: K001528(ABBREVIATED) ATTN: JAMES R VEALE PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 18-JAN-01 N. ATTLEBORO, MA 02760-4153 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REGAIN DESKTOP SRS MEDICAL SYSTEMS, INC. 510(k) NO: K003127(TRADITIONAL) ATTN: LEE BRODY PHONE NO : 781-229-1500 14950 N.E. 95TH ST. SE DECISION MADE: 04-JAN-01 REDMOND, WA 98052 510(k) STATEMENT DEVICE: ORION PLATINUM SRS MEDICAL SYSTEMS, INC. 510(k) NO: K003367(TRADITIONAL) ATTN: LEE BRODY PHONE NO : 781-229-1500 14950 N.E. 95TH ST. SE DECISION MADE: 04-JAN-01 REDMOND, WA 98052 510(k) STATEMENT DEVICE: ULTIMUM EV HEMOSTASIS INTRODUCER (14F),ULTIMUM EV HEMOSTASIS INT ST.JUDE MEDICAL 510(k) NO: K003729(SPECIAL) ATTN: ANGELA BYLAND PHONE NO : 952-352-9716 14901 DEVEAU PLACE SE DECISION MADE: 03-JAN-01 MINNETONKA, MN 55345 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERIS DEEPSITE FIBER OPTIC SURGICAL LIGHT STERIS CORP. 510(k) NO: K003577(ABBREVIATED) ATTN: RAYMOND URSICK PHONE NO : 440-354-2600 2720 GUNTER PARK EAST SE DECISION MADE: 29-JAN-01 MONTGOMERY, AL 36109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STICK STICK TECH LTD. 510(k) NO: K003333(TRADITIONAL) ATTN: WILLIAM M TROETEL PHONE NO : 914-664-1640 80 PARKWAY WEST SE DECISION MADE: 04-JAN-01 MOUNT VERNON, NY 10552 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STICK NET STICK TECH LTD. 510(k) NO: K003334(TRADITIONAL) ATTN: WILLIAM M TROETEL PHONE NO : 914-664-1640 80 PARKWAY WEST SE DECISION MADE: 08-JAN-01 MOUNT VERNON, NY 10552 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STOCKERT A242 AND A252 SERIES ARTERIAL FEMORAL CANNULAE STOECKERT INSTRUMENTE 510(k) NO: K001961(ABBREVIATED) ATTN: LYNNE LEONARD PHONE NO : 303-467-6586 14401 W. 65TH WAY SE DECISION MADE: 25-JAN-01 ARVADA, CO 80004-3599 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STOCKERT A272 SERIES PEDIATRIC AORTIC CANNULAE STOECKERT INSTRUMENTE 510(k) NO: K002273(ABBREVIATED) ATTN: BARBARA WATSON PHONE NO : 303-425-5508 14401 W. 65TH WAY SE DECISION MADE: 29-JAN-01 ARVADA, CO 80004-3599 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT AND ACM AND MIXEVACII STRYKER CORP. 510(k) NO: K002652(TRADITIONAL) ATTN: SUZANNE VELAZQUEZ PHONE NO : 616-323-7700 4100 MILHAM AVENUE SE DECISION MADE: 26-JAN-01 KALAMAZOO, MI 49008 510(k) STATEMENT DEVICE: STRYKER NAVIGATION SYSTEM-SPINE & FLUOROSCOPY MODULES STRYKER INSTRUMENTS 510(k) NO: K003111(TRADITIONAL) ATTN: NICOLE PETTY PHONE NO : 616-323-7700 4100 EAST MILHAM AVE. SE DECISION MADE: 04-JAN-01 KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRYKER REMOTE SURGICAL PLANNING SYSTEM STRYKER INSTRUMENTS 510(k) NO: K004027(SPECIAL) ATTN: NICOLE PETTY PHONE NO : 616-323-7700 4100 EAST MILHAM AVENUE SE DECISION MADE: 24-JAN-01 KALAMAZOO,, MI 49001 510(k) STATEMENT DEVICE: SPLINE DENTAL IMPLANT SYSTEM SULZER CALCITEK INC. 510(k) NO: K010073(SPECIAL) ATTN: FOSTER BOOP PHONE NO : 760-929-4104 1900 ASTON AVE. SE DECISION MADE: 19-JAN-01 CARLSBAD, CA 92008-7308 510(k) STATEMENT DEVICE: SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESIS SULZER CARBOMEDICS, INC. 510(k) NO: K002007(TRADITIONAL) ATTN: LISA O'CONNER PHONE NO : 512-435-3523 1300 EAST ANDERSON LN. SE DECISION MADE: 25-JAN-01 AUSTIN, TX 78752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNICONDYLAR INTERPOSITIONAL SPACER SULZER ORTHOPEDICS, INC. 510(k) NO: K003269(TRADITIONAL) ATTN: MITCHELL A DHORITY PHONE NO : 512-432-9202 9900 SPECTRUM DR. SE DECISION MADE: 04-JAN-01 AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SULZER ORTHOPEDICS ANATOMICAL SHOULDER CEMENTED HUMERAL STEM SULZER ORTHOPEDICS, INC. 510(k) NO: K003832(SPECIAL) ATTN: MITCHELL A DHORITY PHONE NO : 512-432-9900 9900 SPECTRUM DR. SE DECISION MADE: 04-JAN-01 AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EDTA ROOT CANAL CLEANSER SUPER GLIDE, INC. 510(k) NO: K003422(TRADITIONAL) ATTN: VICTOR L RATKUS PHONE NO : 802-864-0461 227 COLCHESTER AVE. SE DECISION MADE: 19-JAN-01 BURLINGTON, VT 05401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PVA FOAM EMBOLIZATION PARTICLES SURGICA CORPORATION 510(k) NO: K001678(TRADITIONAL) ATTN: LOU MATSON PHONE NO : 916-933-5056 5090 ROBERT J. MATHEWS PKWY. SE DECISION MADE: 25-JAN-01 #4 510(k) SUMMARY AVAILABLE FROM FDA EL DORADO HILLS, CA 95762 DEVICE: TIANXIE SUZHOU TIANYI ACUPUNCTURE INSTRUME510(k) NO: K003748(TRADITIONAL) ATTN: HENRY WOO PHONE NO : 714-545-3181 1491 BAKER STREET SE DECISION MADE: 26-JAN-01 COSTA MESA, CA 92626 510(k) STATEMENT DEVICE: KENZ ECG 108 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS; KENZ EC SUZUKEN CO., LTD. 510(k) NO: K001896(TRADITIONAL) ATTN: CAROLANN KOTULA PHONE NO : 770-985-8203 55 NORTHERN BLVD. SE DECISION MADE: 08-JAN-01 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA GREAT NECK, NY 11021 DEVICE: TEMP-BOND NE 2 SYBRON DENTAL SPECIALTIES, INC. 510(k) NO: K003658(TRADITIONAL) ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484 1717 WEST COLLINS AVENUE SE DECISION MADE: 04-JAN-01 ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHACOGARD SYNTEC, INC. 510(k) NO: K002932(TRADITIONAL) ATTN: D OGROWSKY PHONE NO : 314-968-4647 733 MANSION RD. SE DECISION MADE: 04-JAN-01 WINFIELD, MO 63389 510(k) STATEMENT DEVICE: SYNTHES (USA) RESORBABLE TACK SYSTEM SYNTHES (USA) 510(k) NO: K000560(TRADITIONAL) ATTN: BONNIE J SMITH PHONE NO : 610-647-9700 1690 RUSSELL ROAD SE DECISION MADE: 09-JAN-01 POST OFFICE BOX 1766 510(k) SUMMARY AVAILABLE FROM FDA PAOLI, PA 19301 DEVICE: MAXILLARY DISTRACTOR SYNTHES (USA) 510(k) NO: K003393(TRADITIONAL) ATTN: THOMAS M MAGUIRE PHONE NO : 610-647-9700 P.O. BOX 1766 SE DECISION MADE: 17-JAN-01 1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA PAOLI, PA 19301-1222 DEVICE: EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS SYVA CO., DADE BEHRING INC. 510(k) NO: K003341(TRADITIONAL) ATTN: PAUL L ROGER PHONE NO : 408-239-2309 P.O. BOX 49013 SE DECISION MADE: 22-JAN-01 3403 YERBA BUENA ROAD 510(k) SUMMARY AVAILABLE FROM FDA SAN JOSE, CA 95161-9013 DEVICE: CONTROL MALE CONDOMS OF NATURAL RUBBER LATEX TECNILATEX S.A. 510(k) NO: K003375(ABBREVIATED) ATTN: JOSE M VAZQUEZ MARTIN PHONE NO : 349 164 99066 APDO. CORREOS, 156 SE DECISION MADE: 28-JAN-01 C/FRAGUAS, 2 ALCORCON 510(k) STATEMENT MADRID, SPAIN 28923 DEVICE: FILAC FAS TEMP ELECTRONIC THERMOMETER THE KENDALL COMPANY 510(k) NO: K003313(TRADITIONAL) ATTN: KELLY J ROWLAND PHONE NO : 314-895-4100 444 MCDONNELL BLVD. SE DECISION MADE: 11-JAN-01 HAZELWOOD, MO 63042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KENDALL-LTP TURNER SAVE-A-LINE THE LUDLOW COMPANY, LP 510(k) NO: K003511(TRADITIONAL) ATTN: KATHLEEN M MURPHY PHONE NO : 413-593-8288 TWO LUDLOW PARK SE DECISION MADE: 24-JAN-01 CHICOPEE, MA 01022 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FORMULA ONE POWDERED LATEX EXAMINATION GLOVE, WITH PROTEIN CONTE TILLOTSON HEALTHCARE CORPORATION 510(k) NO: K002719(TRADITIONAL) ATTN: F.W. PERRELLA PHONE NO : 603-472-6600 360 ROUTE 101 SE DECISION MADE: 26-JAN-01 BEDFORD, NH 03110-5030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PALFIQUE ESTELITE LV TOKUYAMA AMERICA, INC. 510(k) NO: K002863(TRADITIONAL) ATTN: DANIEL J MANELLI PHONE NO : 202-261-1040 2000 M STREET NW SE DECISION MADE: 04-JAN-01 SUITE 700 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20036 DEVICE: LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901 TRACE AMERICA, INC. 510(k) NO: K003583(TRADITIONAL) ATTN: THOMAS DOLLAR PHONE NO : 817-607-1717 845 AVE. G EAST SE DECISION MADE: 17-JAN-01 ARLINGTON, TX 76011 510(k) STATEMENT DEVICE: U-SYSTEMS ULTRASOUND SYSTEM USI-2000 U-SYSTEMS, INC. 510(k) NO: K003479(TRADITIONAL) ATTN: SHEILA W PICKERING PHONE NO : 650-969-6114 2081 LONGDEN CIRCLE SE DECISION MADE: 18-JAN-01 LOS ALTOS,, CA 94204 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNIGRAFT UNICARE BIOMEDICAL 510(k) NO: K003457(TRADITIONAL) ATTN: STAN YANG PHONE NO : 949-362-1772 25951 LA CUESTA AVENUE SE DECISION MADE: 09-JAN-01 LAGUNA HILLS, CA 92653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: U2 HIP STEM, TI POROUS COATED UNITED ORTHOPEDIC CORP. 510(k) NO: K003237(TRADITIONAL) ATTN: MELLEN LIU PHONE NO : 886 3 5773351 57 PARK AVE. 2, SCIENCE PARK SE DECISION MADE: 10-JAN-01 HSINCHU, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM UNIX ELECTRONIC CO. LTD. 510(k) NO: K002791(TRADITIONAL) ATTN: GUENTER GINSBERG PHONE NO : 941-948-2001 11820 RED HIBSCUS DRIVE SE DECISION MADE: 29-JAN-01 BONITA SPRINGS, FL 34135 510(k) STATEMENT DEVICE: GP GENERAL PURPOSE DRAINAGE SET, MINI-PIGTAIL DRAINAGE CATHETER URESIL CORP. 510(k) NO: K003753(SPECIAL) ATTN: CHARLES P GILL PHONE NO : 847-982-1154 5418 WEST TOUHY AVE. SE DECISION MADE: 04-JAN-01 SKOKIE, IL 60077 510(k) STATEMENT DEVICE: VITREA 2 CT PERFUSION OPTION VITAL IMAGES, INC. 510(k) NO: K003639(TRADITIONAL) ATTN: ROBERT C SAMEC PHONE NO : 612-915-8001 3300 FERNBROOK LANE NORTH SE DECISION MADE: 23-JAN-01 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA PLYMOUTH, MN 55447 DEVICE: WAKO CRP-UL, CRP-UL CALIBRATOR SET WAKO CHEMICALS, USA, INC. 510(k) NO: K003342(TRADITIONAL) ATTN: TONYA MALLOY PHONE NO : 804-714-1925 1600 BELLWOOD RD. SE DECISION MADE: 22-JAN-01 RICHMOND, VA 23237 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE WANG & LI, INC. 510(k) NO: K003415(TRADITIONAL) ATTN: ANN D MCGONIGLE PHONE NO : 508-358-9114 2026 COYLE ST. SE DECISION MADE: 03-JAN-01 BROOKLYN, NY 11229 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WATER PURIFICATION SYSTEM WATER & POWER TECHNOLOGIES, INC. 510(k) NO: K994292(TRADITIONAL) ATTN: BARRY PEARCE PHONE NO : 972-355-9700 3535 FIREWHEEL DR. SE DECISION MADE: 02-JAN-01 SUITE A 510(k) SUMMARY AVAILABLE FROM FDA FLOWER MOUND, TX 75028-2628 DEVICE: BURN JEL PLUS WATER-JEL TECHNOLOGIES, LLC 510(k) NO: K003396(TRADITIONAL) ATTN: MICHAEL PISANI PHONE NO : 201-507-8300 243 VETERANS BLVD. SE DECISION MADE: 11-JAN-01 CARLSTADT, NJ 07072 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BPC-3000 PERSONAL BLOOD PRESSURE COMMUNICATOR, MODEL 52520 WELCH ALLYN, INC. 510(k) NO: K001543(TRADITIONAL) ATTN: ZORAN PSENICNIK PHONE NO : 315-685-4400 4341 STATE STREET RD. SE DECISION MADE: 29-JAN-01 P.O. BOX 220 510(k) SUMMARY AVAILABLE FROM FDA SKANEATELES FALLS, NY 13153-0220 DEVICE: WELCH ALLYN 11800 OPTHALMOSCOPE WELCH ALLYN, INC. 510(k) NO: K003376(ABBREVIATED) ATTN: COLIN WOLFF PHONE NO : 315-685-2525 4341 STATE STREET RD. SE DECISION MADE: 25-JAN-01 P.O. BOX 220 510(k) SUMMARY AVAILABLE FROM FDA SKANEATELES FALLS, NY 13153-0220 DEVICE: STERILE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, WIT WRP ASIA PACIFIC SDN. BHD. 510(k) NO: K003653(TRADITIONAL) ATTN: YUE WAH CHOW PHONE NO : 011 603 87061486 LOT 1, JALAN 3, SE DECISION MADE: 26-JAN-01 KAWASAN PERUSAHAAN BANDAR BARU 510(k) SUMMARY AVAILABLE FROM FDA SALAK TINGGI, SEPANG SELANGOR, MALAYSIA 43900 DEVICE: POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NONSTERILE WRP ASIA PACIFIC SDN. BHD. 510(k) NO: K010072(TRADITIONAL) ATTN: YUE W CHOW PHONE NO : 603 870 61486 LOT 1, JALAN 3, SE DECISION MADE: 26-JAN-01 KAWASAN PERUSAHAAN BANDAR BARU 510(k) SUMMARY AVAILABLE FROM FDA SALAK TINGGI, SEPANG SELANGOR, MALAYSIA 43900 DEVICE: ELECTROSURGICAL PROBES AND DEVICES-GELTX XIMED/PROSURE/INJECTX 510(k) NO: K002269(TRADITIONAL) ATTN: ASHVIN DESAI PHONE NO : 408-945-4044 2193 TRADE ZONE BLVD. SE DECISION MADE: 04-JAN-01 SAN JOSE, CA 95131 510(k) STATEMENT DEVICE: ZYNERGY BALLOONPACE BALLOON GUIDED PACING AND MONITORING CATHETE ZCV ,INC. 510(k) NO: K002603(TRADITIONAL) ATTN: JING ZHANG PHONE NO : 732-225-3800 298 FERNWOOD AVE. SE DECISION MADE: 08-JAN-01 EDISON, NJ 08837 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZOE MEDICAL NIGHTINGALE MONITORING SYSTEM ZOE MEDICAL, INCORPORATED 510(k) NO: K001775(TRADITIONAL) ATTN: PAUL M FITZMEYER PHONE NO : 978-887-1407 460 BOSTON STREET SE DECISION MADE: 12-JAN-01 TOPSFIELD, MA 01983-1223 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 236 TOTAL WITH SUMMARIES 171 TOTAL WITH STATEMENTS 65
Updated 4/2/2001
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