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Medical Devices
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January 2001 510(k) Clearances
SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE)
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD 01-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
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