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Medical Devices
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September 2007 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-SEP-2007 THROUGH 30-SEP-2007
DEVICE: MODIFICATION TO RX HERCULINK ELITE BILIARY STENT SYSTEM
ABBOTT VASCULAR INC. 510(k) NO: K063481(TRADITIONAL)
ATTN: NADINE SMITH PHONE NO : 951-914-2292
3200 LAKESIDE SE DECISION MADE: 14-SEP-07
SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100A
ACCLARENT, INC. 510(k) NO: K071845(TRADITIONAL)
ATTN: KERI YEN PHONE NO : 650-687-5874
1525-B O'BRIEN DR. SE DECISION MADE: 28-SEP-07
MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
ACCURAY INCORPORATED 510(k) NO: K072504(SPECIAL)
ATTN: ANNE SCHLAGENHAFT PHONE NO : 408-716-4628
1310 CHESAPEAKE TERRACE SE DECISION MADE: 21-SEP-07
SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACME TALON PEDICLE SCREW
ACME SPINE, LLC. 510(k) NO: K071824(SPECIAL)
ATTN: J. D WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD. SE DECISION MADE: 04-SEP-07
ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMFORTPRESS VASCULAR COMPRESSION ASSIST DEVICE
ADVANCED VASCULAR DYNAMICS 510(k) NO: K072167(SPECIAL)
ATTN: HERBERT J SEMLER PHONE NO : 503-223-2333
2326 NW EVERETT ST. SE DECISION MADE: 06-SEP-07
PORTLAND, OR 97210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S4 SPINAL SYSTEM
AESCULAP IMPLANT SYSTEMS 510(k) NO: K071945(SPECIAL)
ATTN: KATHY A RACOSKY PHONE NO : 610-984-9291
3773 CORPORATE PWKY. SE DECISION MADE: 20-SEP-07
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLUMBUS TOTAL KNEE SYSTEM MIOS CR/PS TIBIAL TRAY
AESCULAP IMPLANT SYSTEMS, INC. 510(k) NO: K071499(TRADITIONAL)
ATTN: KATHY A RACOSKY PHONE NO : 610-984-9291
3773 CORPORATE PKWY. SE DECISION MADE: 14-SEP-07
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEWTOM VG COMPUTED TOMOGRAPHY X-RAY SYSTEM
AFP IMAGING CORP. 510(k) NO: K072357(SPECIAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434
49 PLAIN ST. SE DECISION MADE: 18-SEP-07
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: JAZZ BLOOD GLUCOSE MONITORING SYSTEM
AGAMATRIX 510(k) NO: K072413(SPECIAL)
ATTN: CONNIE HERTEL PHONE NO : 603-328-6000
10 MAOR PARKWAY SE DECISION MADE: 27-SEP-07
SALEM, NH 03079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALVEOLUS AERO DV TRACHEOBRONCHIAL STENT SYSTEM
ALVEOLUS, INC 510(k) NO: K071604(TRADITIONAL)
ATTN: DONALD V CANAL PHONE NO : 704-926-4850
9013 PERIMETER WOODS DR. SE DECISION MADE: 19-SEP-07
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
CHARLOTTE, NC 28216
DEVICE: INTRAVASCULAR INTRODUCER SYSTEM
APPLIED MEDICAL RESOURCES CORP. 510(k) NO: K063658(SPECIAL)
ATTN: CHERYL BLAKE PHONE NO : 949-713-8327
22872 AVENIDA EMPRESA SE DECISION MADE: 12-SEP-07
RANCHO SANTA MARGARITA, CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT
ARROW INTL., INC. 510(k) NO: K071998(SPECIAL)
ATTN: KIRSTEN STOWELL PHONE NO : 610-378-0131
P.O. BOX 12888 SE DECISION MADE: 26-SEP-07
READING, PA 19612-2888 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPORTMESH OR ARTELON TISSUE REINFORCEMENT
ARTIMPLANT AB 510(k) NO: K071887(TRADITIONAL)
ATTN: TERRY S POWELL PHONE NO : 202-546-1262
719 A STREET NE SE DECISION MADE: 18-SEP-07
WASHINGTON, DC 20002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRECIOUS PLUS GUIDE CATHETER
ASAHI INTECC CO., LTD. 510(k) NO: K072316(SPECIAL)
ATTN: YOSHI TERAI PHONE NO : 949-756-8252
2500 RED HILL AVE, SUITE 210 SE DECISION MADE: 17-SEP-07
SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASAHI PTCA GUIDE WIRE, X-TREME
ASAHI INTECC CO., LTD. 510(k) NO: K072431(SPECIAL)
ATTN: YOSHI TERAI PHONE NO : 949-756-8252
2500 RED HILL AVE, SUITE 210 SE DECISION MADE: 26-SEP-07
SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIASCOPE V
ASTRON CLINICA LIMITED 510(k) NO: K062736(TRADITIONAL)
ATTN: E.J. SMITH PHONE NO : 410-451-0639
1676 VILLAGE GREEN SE DECISION MADE: 14-SEP-07
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
CROFTON, MD 21114
DEVICE: SAVE-SIMPLIFIED AUTOMATED VENTILATOR, MODELS: 550X10, 600X10 AND
AUTOMEDX INC. 510(k) NO: K071221(TRADITIONAL)
ATTN: JAMES D EVANS PHONE NO : 301-916-9508
12321 MIDDLEBROOK RD SE DECISION MADE: 06-SEP-07
SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA
GERMANTOWN, MD 20874
DEVICE: AUTOSAFE-REFLEX SAFETY NEEDLE, AUTOSAFE ADVANTAGE SAFETY NEEDLE
AUTOSAFE-REFELX INC. 510(k) NO: K071567(ABBREVIATED)
ATTN: JOHN D STEPHENS PHONE NO :
1025 NINE NORTH DR., SUITE K SE DECISION MADE: 14-SEP-07
ALPHARETTA, GA 30004 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: DORADO PTA BALLOON DILATATION CATHETER
BARD PERIPHERAL VASCULAR, INC. 510(k) NO: K072283(TRADITIONAL)
ATTN: GENEVIEVE BALUTOWSKI PHONE NO : 480-303-2524
1625 WEST 3RD ST. SE DECISION MADE: 19-SEP-07
P.O. BOX 1740 510(k) SUMMARY AVAILABLE FROM FDA
TEMPE, AZ 85280 THIRD PARTY REVIEW
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MINOCYCLINE (GP) 1-32 U
BECTON, DICKINSON & CO. 510(k) NO: K070809(TRADITIONAL)
ATTN: MONICA E GIGUERE PHONE NO : 410-316-4287
7 LOVETON CIR. SE DECISION MADE: 24-SEP-07
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POCKETCPR
BIO-DETEK, INC. 510(k) NO: K071321(TRADITIONAL)
ATTN: MARK TOTMAN PHONE NO : 401-729-1400
525 NARRAGANSETT PARK DR. SE DECISION MADE: 12-SEP-07
PAWTUCKET, RI 02861-4323 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MRSASELECT
BIO-RAD 510(k) NO: K070361(TRADITIONAL)
ATTN: FRAN WHITE PHONE NO : 978-927-3808
163 CABOT ST. SE DECISION MADE: 13-SEP-07
BEVERLY, MA 01915 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO HYPERQ SYSTEM
BIOLOGICAL SIGNAL PROCESSING, LTD.510(k) NO: K072389(SPECIAL)
ATTN: GEORGE J HATTUB PHONE NO : 508-479-6116
291 HILLSIDE AVENUE SE DECISION MADE: 18-SEP-07
SOMERSET, MA 02726 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIBONE 80
BIOMATLANTE 510(k) NO: K071121(TRADITIONAL)
ATTN: ADELINE FILLIATRE PHONE NO : 33 228 020009
5, RUE EDOUARD BELIN SE DECISION MADE: 11-SEP-07
VIGNEUX DE BRETAGNE, FRANCE 44360 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK 2 GRAM NEGATIVE LEVOFLOXACIN
BIOMERIEUX, INC. 510(k) NO: K072038(TRADITIONAL)
ATTN: JOLYN TENLIADO PHONE NO : 314-731-8386
595 ANGLUM RD. SE DECISION MADE: 12-SEP-07
HAZELWOOD, MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOMET FEMORAL LOCKING NAIL SYSTEM
BIOMET MANUFACTURING CORP. 510(k) NO: K072161(TRADITIONAL)
ATTN: BECKY EARL PHONE NO : 574-267-6639
PO BOX 587 SE DECISION MADE: 20-SEP-07
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOMET MICROFIXATION LACTOSORB PECTUS STABILIZER
BIOMET MICROFIXATION, INC. 510(k) NO: K071577(TRADITIONAL)
ATTN: KIM REED PHONE NO : 904-741-4400
1520 TRADEPORT DR. SE DECISION MADE: 06-SEP-07
JACKSONVILLE, FL 32218 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SLEEVE AND BUTTON SOFT TISSUE DEVICES
BIOMET SPORTS MEDICINE, INC. 510(k) NO: K071704(TRADITIONAL)
ATTN: ELIZABETH WRAY PHONE NO : 574-267-6639
56 EAST BELL DRIVE SE DECISION MADE: 17-SEP-07
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: HARPOON SUTURE ANCHOR
BIOMET SPORTS MEDICINE, INC. 510(k) NO: K071816(TRADITIONAL)
ATTN: ELIZABETH WRAY PHONE NO : 574-267-6639
P.O. BOX 587 SE DECISION MADE: 20-SEP-07
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EOS
BIOSPACE MED 510(k) NO: K071546(TRADITIONAL)
ATTN: JOHN J SMITH PHONE NO : 202-637-3638
555 THIRTEENTH ST. NW SE DECISION MADE: 18-SEP-07
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ILAB ULTRASOUND IMAGING SYSTEM, VERSION 1.3
BOSTON SCIENTIFIC CORP. 510(k) NO: K072517(SPECIAL)
ATTN: CHRISTINE DUNBAR PHONE NO : 510-624-2569
47900 BAYSIDE PARKWAY SE DECISION MADE: 26-SEP-07
FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRAINSUITE NET
BRAINLAB AG 510(k) NO: K070556(TRADITIONAL)
ATTN: RAINER BIRKENBACH PHONE NO : 49 89 9915680
KAPELLENSTRASSE 12 SE DECISION MADE: 25-SEP-07
FELDKIRCHEN, GERMANY 85622 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRM3 BRAIN MONITOR
BRAINZ INSTRUMENTS LTD. 510(k) NO: K071449(TRADITIONAL)
ATTN: CHRIS MANDER PHONE NO : 64 9 9788855
25 CARBINE ROAD MT. WELLINGTON SE DECISION MADE: 14-SEP-07
PO BOX 51-078, PARURANGA 510(k) SUMMARY AVAILABLE FROM FDA
AUCKLAND, NEW ZEALAND THIRD PARTY REVIEW
DEVICE: BIOZ DX HEMODYNAMIC MONITOR WITH PHILIPS 12-LEAD ECG, MODEL 5100
CARDIODYNAMICS INTERNATIONAL CORP.510(k) NO: K070156(TRADITIONAL)
ATTN: PAUL L SHAFFER PHONE NO : 858-535-0202
6175 NANCY RIDGE DR., #300 SE DECISION MADE: 26-SEP-07
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BOOMERANG CATALYST/BOOMERANG CATALYST II SYSTEM
CARDIVA MEDICAL, INC. 510(k) NO: K072297(SPECIAL)
ATTN: KIT CARIQUITAN PHONE NO : 408-400-0856
155 MOFFETT PARK DR., SE DECISION MADE: 12-SEP-07
SUITE A-210 510(k) SUMMARY AVAILABLE FROM FDA
SUNNYVALE, CA 94089
DEVICE: VISULAS TRION
CARL ZEISS MEDITEC AG 510(k) NO: K072514(TRADITIONAL)
ATTN: KENT W JONES PHONE NO : 925-557-4353
5160 HACIENDA DRIVE SE DECISION MADE: 21-SEP-07
DUBLIN, CA 94568 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CYSTIC FIBROSIS GENOTYPING ASSAY, MODEL 6L20-01
CELERA DIAGNOSTICS 510(k) NO: K062028(TRADITIONAL)
ATTN: VICTORIA MACKINNON PHONE NO : 510-749-4389
1401 HARBOR BAY PKWY. SE DECISION MADE: 07-SEP-07
ALAMEDA, CA 94502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AQUADEX FLEXFLOW SYSTEM
CHF SOLUTIONS, INC. 510(k) NO: K071854(SPECIAL)
ATTN: CHRIS SCAVOTTO PHONE NO : 763-463-4621
7601 NORTHLAND DR. STE. 170 SE DECISION MADE: 07-SEP-07
BROOKLYN PARK, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TROJAN THINTENSITY BRAND MALE LATEX CONDOM
CHURCH & DWIGHT CO., INC. 510(k) NO: K071272(ABBREVIATED)
ATTN: STEPHEN C KOLAKOWSKY PHONE NO : 609-279-7748
469 NORTH HARRISON STREET SE DECISION MADE: 12-SEP-07
PRINCETON, NJ 08543 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE TEMPERATURE PROBES/SENSORS AND INSTRUMENT CABLES
CINCINNATI SUB-ZERO PRODUCTS, INC 510(k) NO: K070339(TRADITIONAL)
ATTN: DAN WITTMER PHONE NO : 513-326-9021
1201 MOSTELLAR ROAD SE DECISION MADE: 26-SEP-07
CINCINNATI, OH 45241 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIDUCIAL MARKERS
CIVCO 510(k) NO: K071614(TRADITIONAL)
ATTN: JIM LEONG PHONE NO : 319-656-4447
1401 8TH ST. SE SE DECISION MADE: 11-SEP-07
ORANGE CITY, IA 51041-0320 510(k) STATEMENT
DEVICE: GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION
CLINICAL INNOVATIONS, LLC 510(k) NO: K061539(TRADITIONAL)
ATTN: WM DEAN WALLACE PHONE NO : 801-268-8200
747 WEST 4170 SOUTH SE DECISION MADE: 20-SEP-07
MURRAY, UT 84123 510(k) STATEMENT
DEVICE: DISPOSABLE HIGH PRESSURE INJECTION LINES WITH AND WITHOUT ROTATI
COEUR, INC. 510(k) NO: K071196(TRADITIONAL)
ATTN: DEBRA F MANNING PHONE NO : 615-547-7923
704 CADET COURT SE DECISION MADE: 06-SEP-07
LEBANON, TN 37087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONFORMIS METAL BACKED TIBIAL COMPONENT
CONFORMIS, INC. 510(k) NO: K072368(TRADITIONAL)
ATTN: MICHAEL SHARP PHONE NO : 781-860-5111
2 FOURTH AVENUE SE DECISION MADE: 20-SEP-07
BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS AND TRUPUSH CO
CORDIS NEUROVASCULAR, INC. 510(k) NO: K071962(SPECIAL)
ATTN: AMARILYS MACHADO PHONE NO : 786-313-6493
14000 N.W. 57TH CT. SE DECISION MADE: 26-SEP-07
MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FITMATE SERIES
COSMED S.R.L. 510(k) NO: K071533(TRADITIONAL)
ATTN: ROBERT SCHIFF PHONE NO : 973-227-1830
1129 BLOOMFIELD AVENUE SE DECISION MADE: 28-SEP-07
WEST CALDWELL, NJ 07000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CURE CATHETER
CURE MEDICAL LLC. 510(k) NO: K072539(TRADITIONAL)
ATTN: JAMES SMITH PHONE NO : 949-340-7261
28241 CROWN VALLEY PARKWAY SE DECISION MADE: 13-SEP-07
SUITE 510 510(k) SUMMARY AVAILABLE FROM FDA
LAGUNA NIGUEL, CA 92677 THIRD PARTY REVIEW
DEVICE: DIMENSION VISTA PROTEIN 1 CALIBRATOR, PROTEIN1 CONTROL L,M,H
DADE BEHRING, INC. 510(k) NO: K071980(TRADITIONAL)
ATTN: ANNA MARIE ENNIS PHONE NO : 302-631-9352
P.O. BOX 6101 SE DECISION MADE: 11-SEP-07
NEWARK,, DE 19714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIBRINOGEN CALIBRATOR KIT
DADE BEHRING, INC. 510(k) NO: K072304(TRADITIONAL)
ATTN: RADAMES RIESGO PHONE NO : 305-480-7558
P.O. BOX 6101; MS 514 SE DECISION MADE: 19-SEP-07
GLASGOW BLDG. 500 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101
DEVICE: NETGUARD AUTOMATED CLINICIAN ALERT SYSTEM, MODEL 0998-00-1600-XX
DATASCOPE CORP. 510(k) NO: K071805(ABBREVIATED)
ATTN: KATHLEEN KRAMER PHONE NO : 201-995-8169
800 MACARTHUR BLVD. SE DECISION MADE: 25-SEP-07
MAHWAH, NJ 07430-0619 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTEOGRAF/N-300
DENTSPLY INTERNTIONAL 510(k) NO: K071817(SPECIAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511
221 W. PHILADELPHIA ST. STE.60 SE DECISION MADE: 04-SEP-07
SUSQUEHANNA COMMERCE CRT. WEST 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17404
DEVICE: DEPUY CORAIL AMT DYSPLASIA HIP PROSTHESIS
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K070554(SPECIAL)
ATTN: KATHY HARRIS PHONE NO : 574-372-7082
700 ORTHOPAEDIC DR. SE DECISION MADE: 11-SEP-07
P.O BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K071016(TRADITIONAL)
ATTN: KATHY HARRIS PHONE NO : 574-372-7082
700 ORTHOPAEDIC DR. SE DECISION MADE: 04-SEP-07
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DELTA XTEND REVERSE SHOULDER MODULAR STEM
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K071379(TRADITIONAL)
ATTN: NATALIE S HECK PHONE NO : 574-372-7469
700 ORTHOPAEDIC DR. SE DECISION MADE: 11-SEP-07
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEPUY DELTA TS CERAMIC FEMORAL HEADS
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K071830(TRADITIONAL)
ATTN: RHONDA MYER PHONE NO : 574-371-4297
700 ORTHOPAEDIC DR. SE DECISION MADE: 28-SEP-07
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXPEDIUM SPINE SYSTEM
DEPUY SPINE, INC. 510(k) NO: K070387(TRADITIONAL)
ATTN: CHRISTOPHER KLACZYK PHONE NO : 508-828-2852
325 PARAMOUNT DR. SE DECISION MADE: 18-SEP-07
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIAGNOSTIC HYBRIDS' D3 DFA CHLAMYDIAE CULTURE CONFIRMATION KIT
DIAGNOSTIC HYBRIDS, INC. 510(k) NO: K063675(TRADITIONAL)
ATTN: GAIL GOODRUM PHONE NO : 740-593-1784
350 WEST STATE ST. SE DECISION MADE: 24-SEP-07
ATHENS, OH 45701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION K
DIAGNOSTIC HYBRIDS, INC. 510(k) NO: K063798(TRADITIONAL)
ATTN: GAIL GOODRUM PHONE NO : 740-593-1784
350 WEST STATE ST. SE DECISION MADE: 21-SEP-07
ATHENS, OH 45701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRAT
DIAZYME LABORATORIES 510(k) NO: K071971(SPECIAL)
ATTN: CHARLES YU PHONE NO : 858-455-4761
12889 GREGG COURT SE DECISION MADE: 17-SEP-07
POWAY, CA 92064 510(k) STATEMENT
DEVICE: GLOBUS GENESY 1100 STIMULATOR
DOMINO S.R.L. 510(k) NO: K071431(TRADITIONAL)
ATTN: GIOVANNI M CIRIANI PHONE NO : 860-539-1309
18 EUSTACE DRIVE SE DECISION MADE: 21-SEP-07
WEST HARTFORD, CT 06110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELLIPSE JUVIA, MODEL 9EJU7465
ELLIPSE A/S 510(k) NO: K072023(TRADITIONAL)
ATTN: OLE KOFOD PHONE NO : 45 451 76863
AGERN ALLE 11 SE DECISION MADE: 12-SEP-07
HOERSHOLM, DENMARK DK-2070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYST
ENDIUS, INC. 510(k) NO: K070282(TRADITIONAL)
ATTN: REGINA WAGNER PHONE NO : 508-643-0983
23 WEST BACON ST. SE DECISION MADE: 06-SEP-07
PLAINVILLE, MA 02762 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EGS SEROSAFUSE IMPLANTABLE FASTENERS, ASSOCIATED DELIVERY DEVICE
ENDOGASTRIC SOLUTIONS, INC. 510(k) NO: K071651(TRADITIONAL)
ATTN: MICHAEL A DANIEL PHONE NO : 425-307-9200
8210 154TH AVE. NE SE DECISION MADE: 14-SEP-07
REDMOND, WA 98052 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSSIFUSE BONE SUBSTITUTE MATERIAL
ETEX CORP. 510(k) NO: K072355(SPECIAL)
ATTN: PAMELA W ADAMS PHONE NO : 617-577-7270
38 SIDNEY ST., 3RD FLR SE DECISION MADE: 26-SEP-07
CAMBRIDGE, MA 02139 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HARMONIC 10CM COMBINATION HOOK BLADE
ETHICON ENDO-SURGERY, LLC 510(k) NO: K072203(TRADITIONAL)
ATTN: ELIZABETH MILLER PHONE NO : 513-337-7000
4545 CREEK RD. SE DECISION MADE: 25-SEP-07
CINCINNATI, OH 45242 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMFY SERIES: EV-804, EV-805 & EV-806
EVERYWAY MEDICAL INSTRUMENTS CO., 510(k) NO: K071951(SPECIAL)
ATTN: JAY MANSOUR PHONE NO : 678-908-8180
845 ARONSON LAKE COURT SE DECISION MADE: 05-SEP-07
ROSWELL, GA 30075 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARCHITECT STAT TROPONIN-1; MYOGLOBIN
FISHER DIAGNOSTICS 510(k) NO: K070640(SPECIAL)
ATTN: HEATHER CAMERON PHONE NO : 540-869-8163
8365 VALLEY PIKE, PO BX 307 SE DECISION MADE: 13-SEP-07
MIDDLETOWN, VA 22645 510(k) STATEMENT
DEVICE: AVIAFIT PULSATING LEGBAND
FLOWMEDIC LTD. 510(k) NO: K071744(TRADITIONAL)
ATTN: AHAVA STEIN PHONE NO : 972 976 70002
20 HATAAS STR. SE DECISION MADE: 25-SEP-07
P.O.B. 124 510(k) SUMMARY AVAILABLE FROM FDA
KFAR SABA, ISRAEL 44425
DEVICE: HERPESELECT EXPRESS IGG, HERPESELECT EXPRESS CONTROLS, MODELS RT
FOCUS DIAGNOSTICS, INC. 510(k) NO: K071510(TRADITIONAL)
ATTN: CONSTANCE BRIDGES PHONE NO : 714-220-1900
10703 PROGRESS WAY SE DECISION MADE: 24-SEP-07
CYPRESS, CA 90630-4737 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARCHITECT SIROLIMUS ASSAY
FUJIREBIO DIAGNOSTICS, INC. 510(k) NO: K070822(TRADITIONAL)
ATTN: DIANA LYN DICKSON PHONE NO : 610-240-3917
201 GREAT VALLEY PARKWAY SE DECISION MADE: 28-SEP-07
MALVERN, PA 19355-1308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GAMBRO POLYFLUX HEMODIALYZER, MODEL: HD-C4 SMALL
GAMBRO RENAL PRODUCTS, INC. 510(k) NO: K072232(SPECIAL)
ATTN: KAE MILLER PHONE NO : 303-542-5045
14143 DENVER WEST PARKWAY SE DECISION MADE: 07-SEP-07
LAKEWOOD, CO 80401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: UNITY NETWORK ID
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K071982(SPECIAL)
ATTN: LISA M BAUMHARDT PHONE NO : 414-362-3242
8200 WEST TOWER AVE. SE DECISION MADE: 21-SEP-07
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE LUNAR DPX & PRODIGY SERIES DEXA BONE DENSITOMETERS WITH MOBIL
GE MEDICAL SYSTEMS ULTRASOUND AND 510(k) NO: K072439(SPECIAL)
ATTN: JAMES P RASKOB PHONE NO : 608-826-7425
726 HEARTLAND TRAIL SE DECISION MADE: 14-SEP-07
MADISON, WI 53717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIP'R PC
GLOBAL FABTECH WHEEL CHAIR (SHANGH510(k) NO: K072224(TRADITIONAL)
ATTN: JUNNATA CHANG PHONE NO : 886 422 465396
14F-2, NO.1 LANE 25 SE DECISION MADE: 21-SEP-07
ZHUANGJING ROAD 510(k) SUMMARY AVAILABLE FROM FDA
BANQIAO, TAIPEI COUNTY, CHINA (TAIWAN) 220
DEVICE: GREINER VACUETTE QUICKSHIELD COMPLETE
GREINER BIO-ONE NORTH AMERICA, INC510(k) NO: K072320(SPECIAL)
ATTN: JUDI SMITH PHONE NO : 410-592-2060
P.O. BOX 103 SE DECISION MADE: 14-SEP-07
BALDWIN, MD 21013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NITRILE POWDER FREE EXAMINATION GLOVES (BLUE), NITRILE POWDER FR
HARTALEGA SDN BHD 510(k) NO: K071910(TRADITIONAL)
ATTN: NURUL AISYAH KONG BT ABDULLPHONE NO : 603 327 10277
# 7, KAWASAN PERUSAHAAN SURIA SE DECISION MADE: 06-SEP-07
BATANG BERJUNTAI 510(k) STATEMENT
SELANGOR, DARUL EHSAN, MALAYSIA 45600
DEVICE: MAGNETIC RESONANCE DIAGNOSTIC DEVICE
HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K072279(TRADITIONAL)
ATTN: DOUG THISTLETHWAITE PHONE NO : 330-425-1313
1959 SUMMIT COMMERCE PARK SE DECISION MADE: 21-SEP-07
TWINSBURG, OH 44087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HONEYWELL HOMMED CENTRAL STATION 4.0
HONEYWELL HOMMED, LLC 510(k) NO: K072272(SPECIAL)
ATTN: MICHAEL LEIGH PHONE NO : 262-252-5794
3400 INTERTECH DR. SE DECISION MADE: 07-SEP-07
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
BROOKFIELD, WI 53045
DEVICE: STRYKER MODULAR HIP SYSTEM
HOWMEDICA OSTEONICS CORP 510(k) NO: K071082(TRADITIONAL)
ATTN: VIVIAN KELLY PHONE NO : 201-831-5581
325 CORPORATE DR. SE DECISION MADE: 13-SEP-07
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORIN ADAPTOR SLEEVE
HOWMEDICA OSTEONICS CORP 510(k) NO: K071471(TRADITIONAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-831-5718
325 CORPORATE DR. SE DECISION MADE: 10-SEP-07
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A
HYPHEN BIOMED 510(k) NO: K071255(TRADITIONAL)
ATTN: OLA ANDERSON PHONE NO : 513-570-1979
6560 GOVE COURT SE DECISION MADE: 07-SEP-07
MASON, OH 45040 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PULL TAB SQUEEZE FLUSH
ICU MEDICAL, INC 510(k) NO: K070979(SPECIAL)
ATTN: TRACY BEST PHONE NO : 801-264-1332
4455 ATHERTON DR. SE DECISION MADE: 19-SEP-07
SALT LAKE CITY, UT 84123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMULISA INTRINSIC FACTOR ANTIBODY ELISA
IMMCO DIAGNOSTICS, INC. 510(k) NO: K071346(TRADITIONAL)
ATTN: KEVIN LAWSON PHONE NO : 716-691-0091
60 PINEVIEW DR. SE DECISION MADE: 24-SEP-07
BUFFALO, NY 14228-2120 510(k) STATEMENT
DEVICE: CARDIOPULMONARY EXERCISE TESTING OPTION TO INNOCOR
INNOVISION A/S 510(k) NO: K071911(TRADITIONAL)
ATTN: RICHARD O WOOD PHONE NO : 847-234-7500
1025 EVERETT ROAD SE DECISION MADE: 07-SEP-07
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
LAKE FOREST, IL 60045
DEVICE: 1.5T MRGFUS PELVIC COIL
INSIGHTEC-TXSONICS, INC. 510(k) NO: K071966(TRADITIONAL)
ATTN: NADIR ALIKACEM PHONE NO : 214-630-2000
2777 N. STEMMONS FREEWAY SE DECISION MADE: 05-SEP-07
SUITE 940 510(k) SUMMARY AVAILABLE FROM FDA
DALLAS, TX 75207-2273
DEVICE: P.004 NC ANATOMIC ABUTMENTS
INSTITUT STRAUMANN AG 510(k) NO: K071357(TRADITIONAL)
ATTN: PAIGE SWEENEY PHONE NO : 978-747-2507
60 MINUTEMAN ROAD SE DECISION MADE: 26-SEP-07
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: P.004 NC GOLD ABUTMENT FOR CROWNS
INSTITUT STRAUMANN AG 510(k) NO: K072497(SPECIAL)
ATTN: ELAINE ALAN PHONE NO : 800-448-8168
60 MINUTEMAN ROAD SE DECISION MADE: 26-SEP-07
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMOSIL D-DIMER HS
INSTRUMENTATION LABORATORY CO. 510(k) NO: K070927(TRADITIONAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467
113 HARTWELL AVE. SE DECISION MADE: 17-SEP-07
LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAYFIELD DISPOSABLE AND REUSABLE TITANIUM SKULL PINS
INTEGRA LIFESCIENCES CORPORATION 510(k) NO: K072208(SPECIAL)
ATTN: HELDER A SOUSA PHONE NO : 609-936-6850
311 ENTERPRISE DR. SE DECISION MADE: 07-SEP-07
PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INQU
ISTO TECHNOLOGIES, INC. 510(k) NO: K071428(TRADITIONAL)
ATTN: PATSY J TRISLER PHONE NO : 301-652-5344
5600 WISCONSIN AVE. SE DECISION MADE: 17-SEP-07
#509 510(k) SUMMARY AVAILABLE FROM FDA
CHEVY CHASE, MD 20815
DEVICE: GOLD CUP ELECTRODE, SILVER CUP ELECTRODE AND ELECTRODE WITH AG-A
IVES EEG SOLUTIONS, INC. 510(k) NO: K071118(TRADITIONAL)
ATTN: JOHN R IVES PHONE NO : 613 692 1567
6325 RIDEAU VALLEY DRIVE SE DECISION MADE: 07-SEP-07
MANOTICK, ONTARIO, CANADA K4M 1B3 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CERVITEC PLUS
IVOCLAR VIVADENT, INC. 510(k) NO: K072338(TRADITIONAL)
ATTN: DONNA MARIE HARTNETT PHONE NO : 716-691-0010
175 PINEVIEW DR. SE DECISION MADE: 21-SEP-07
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: JUNIPER CLN1 DERMAL COOLING DEVICE
JUNIPER MEDICAL INC. 510(k) NO: K072152(TRADITIONAL)
ATTN: DONALD V JOHNSON PHONE NO : 925-474-2500
4698 WILLOW RD. SE DECISION MADE: 07-SEP-07
PLEASANTON, CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEGAFIX-C BIOABSORBABLE COMPOSITE INTERFERENCE SCREW, MODEL 287
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K071437(TRADITIONAL)
ATTN: CRYSTAL DIZOL PHONE NO : 310-338-8100
600 CORPORATE POINTE SE DECISION MADE: 12-SEP-07
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KARL STORZ VIDEO RHINO-LARYNGSCOPE SYSTEM, MODEL 11101 SERIES
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K072387(TRADITIONAL)
ATTN: SUSIE CHEN PHONE NO : 310-338-8100
600 CORPORATE POINTE SE DECISION MADE: 13-SEP-07
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO COPIOS BONE VOID FILLER SPONGE & PASTE
KENSEY NASH CORP. 510(k) NO: K072384(SPECIAL)
ATTN: JENNIFER J BOSLEY PHONE NO : 484-713-2173
735 PENNSYLVANIA DRIVE SE DECISION MADE: 21-SEP-07
EXTON, PA 19341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TI2200 TRANSILLUMINATION CABLE
KERR CORPORATION 510(k) NO: K071429(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVENUE SE DECISION MADE: 10-SEP-07
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BACTRACK LCD ALCOHOL DETECTOR
KHN SOLUTIONS, LLC 510(k) NO: K071067(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854
P.O. BOX 7007 SE DECISION MADE: 14-SEP-07
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LANX SPINAL FIXATION SYSTEM
LANX, LLC 510(k) NO: K071877(TRADITIONAL)
ATTN: JANICE M HOGAN PHONE NO : 267-675-4611
1835 MARKET STREET, 28TH FLOOR SE DECISION MADE: 17-SEP-07
PHILADELPHIA, PA 19102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLANET 55
LARSEN & TOUBRO LIMITED 510(k) NO: K071472(TRADITIONAL)
ATTN: HARRY P GUGNANI PHONE NO : 847-303-3906
1821 WALDEN OFFICE SQUARE SE DECISION MADE: 21-SEP-07
SUITE 400 510(k) SUMMARY AVAILABLE FROM FDA
SCHAUMBURG, IL 60173 THIRD PARTY REVIEW
DEVICE: NEURO WAVE 6
LHASA OMS, INC. 510(k) NO: K062003(TRADITIONAL)
ATTN: MARK W SHEEHAN PHONE NO : 781-340-1072
230 LIBBEY PKWY. SE DECISION MADE: 19-SEP-07
WEYMOUTH, MA 02189 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLOODSTOP AND BLOODSTOP IX HEMOSTATIC GAUZE, MODELS BS-10,BS-1
LIFESCIENCE PLUS, INC. 510(k) NO: K071578(TRADITIONAL)
ATTN: AUDREY VITALE PHONE NO : 860-536-4427
22 STONY HILL DRIVE SE DECISION MADE: 27-SEP-07
MYSTIC, CT 06355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CPAP NASAL MASK WITH PILLOWS
LIFESOURCE 510(k) NO: K071773(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239-498-2155
3460 POINTE CREEK COURT #102 SE DECISION MADE: 12-SEP-07
BONITA SPRINGS, FL 34134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIGHTLAS 561 OPTHALMIC PHOTOCOAGULATOR
LIGHTMED CORP. 510(k) NO: K063297(TRADITIONAL)
ATTN: DENNIS DOWELL PHONE NO : 408-540-6371
437 HILLSIDE AVENUE SE DECISION MADE: 20-SEP-07
BEN LOMOND, CA 95005 510(k) STATEMENT
DEVICE: VALIDATE SP1 CALIBRATION VERIFICATION/LINEARITY TEST SET, MODEL
MAINE STANDARDS CO. 510(k) NO: K072246(TRADITIONAL)
ATTN: HOLLY CRESSMAN PHONE NO : 207-892-1300
765 ROOSEVELT TRAIL SE DECISION MADE: 14-SEP-07
WINDHAM, ME 04062-5365 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SANDMAN INTRO
MALLINCKRODT DEVELOPPEMENT FRANCE 510(k) NO: K071575(TRADITIONAL)
ATTN: JAMES BONDS PHONE NO : 925-463-4371
4280 HACIENDA DR. SE DECISION MADE: 10-SEP-07
PLEASANTON, CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODUS TRILOCK 2.0/2.3/2.5
MEDARTIS AG 510(k) NO: K071612(TRADITIONAL)
ATTN: LINDA SCHULZ PHONE NO : 858-792-1235
11234 EL CAMINO REAL, STE 200 SE DECISION MADE: 11-SEP-07
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAXPLUS TRU-SWAB POSITIVE DISPLACEMENT CONNECTOR
MEDEGEN MEDICAL MANUFACTURING SYST510(k) NO: K072542(TRADITIONAL)
ATTN: ALEX MAZZA PHONE NO : 909-605-0314
930 WANNAMAKER AVE. SE DECISION MADE: 25-SEP-07
ONTARIO, CA 91761 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: MODIFCATION TO: SPYGLASS IRRIGATION SYSTEM
MEDICAL SCIENTIFIC, INC. 510(k) NO: K071832(SPECIAL)
ATTN: PAUL NARDELLA JR PHONE NO : 508-880-7313
125 JOHN HANCOCK RD. SE DECISION MADE: 18-SEP-07
TAUNTON, MA 02780 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APEXNRG-BLUE ELECTRONIC APEX LOCATOR
MEDICNRG LTD. 510(k) NO: K071133(TRADITIONAL)
ATTN: GEORGE J HATTUB PHONE NO : 508-479-6116
291 HILLSIDE AVE. SE DECISION MADE: 21-SEP-07
SOMERSET, MA 02726 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO PASSMED SPINAL SYSTEM
MEDICREA TECHNOLOGIES 510(k) NO: K070276(SPECIAL)
ATTN: J. D WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD. SE DECISION MADE: 21-SEP-07
ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDIX NATAL CARE INTENSIVE CARE INCUBATOR, MODELS-NATAL CARE ST-
MEDIX I.C.S.A. 510(k) NO: K070291(TRADITIONAL)
ATTN: JAMES H KNAUSS PHONE NO : 832-285-9423
11874 SOUTH EVELYN CIRCLE SE DECISION MADE: 21-SEP-07
HOUSTON, TX 77071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIDAS REX CURVED BUR
MEDTRONIC POWERED SURGICAL SOLUTIO510(k) NO: K072315(SPECIAL)
ATTN: JEFFREY HENDERSON PHONE NO : 805-968-1546
4620 NORTH BEACH ST. SE DECISION MADE: 18-SEP-07
FORT WORTH, TX 76137 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K070742(TRADITIONAL)
ATTN: LEE GRANT PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 14-SEP-07
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO TSRH SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K072429(SPECIAL)
ATTN: LEE GRANT PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 28-SEP-07
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO:TSRH SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K072317(SPECIAL)
ATTN: LEE GRANT PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 18-SEP-07
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMS-XL CARDIAC ELECTROPHYSIOLOGY SYSTEM
MENNEN MEDICAL LTD. 510(k) NO: K071348(TRADITIONAL)
ATTN: MICHA OESTEREICH PHONE NO : 972 8 9323333
4 HA-YARDEN ST. SE DECISION MADE: 07-SEP-07
P.O. BOX 102 510(k) SUMMARY AVAILABLE FROM FDA
YAVNE, REHOVOT, ISRAEL 76100
DEVICE: FLEXWARMER, MODELS KZ-1 AND KZ-2
MERLYN ASSOCIATES, INC. 510(k) NO: K062644(TRADITIONAL)
ATTN: KAREN CHEN PHONE NO : 714-259-0377
1542 EDINGER AVE., SUITE A SE DECISION MADE: 11-SEP-07
TUSTIN, CA 92780 510(k) STATEMENT
DEVICE: BONEMEDIK, AND BONEMEDIK-S
META BIOMED CO., LTD. 510(k) NO: K070897(TRADITIONAL)
ATTN: TAE-HOON KIM PHONE NO : 824 321 81983
414-12 MO CHOONG DONG SE DECISION MADE: 17-SEP-07
CHONG JU CITY, 510(k) SUMMARY AVAILABLE FROM FDA
CHOONG CHONG BUK DO, REPUBLIC OF KOREA
DEVICE: MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL MT19S1R
MICROLIFE INTELLECTUAL PROPERTY GM510(k) NO: K070590(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 949-429-5825
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 11-SEP-07
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERIPHERAL GUIDING SHEATH
MICRUS DESIGN TECHNOLOGY, INC. 510(k) NO: K070816(TRADITIONAL)
ATTN: MARIANNE GRUNWALDT, MS, CQEPHONE NO : 305-477-2406
9344 N.W. 13TH ST. SE DECISION MADE: 19-SEP-07
MIAMI, FL 33172 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEVADAPTOR, CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM
MIGADA PLANT 510(k) NO: K071741(TRADITIONAL)
ATTN: YOSSI SHACHAR PHONE NO : 972 4 6908800
NORTH INDUSTRIAL ZONE SE DECISION MADE: 24-SEP-07
KIRYAT SHMONA, ISRAEL 10258 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CCRO (CRANIOCEPHALIC CUSTOM REMOLDING ORTHOSIS)
MIKE MINER 510(k) NO: K070694(TRADITIONAL)
ATTN: MIKE MINER PHONE NO : 801-547-0369
1098 EAST MUTTON HOLLOW SE DECISION MADE: 10-SEP-07
KAYSVILLE, UT 84037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIM 4.1 (SEASTAR)
MIMVISTA CORP. 510(k) NO: K071964(TRADITIONAL)
ATTN: PETER SIMMELINK PHONE NO : 216-896-9798
25200 CHAGRIN BLVD. SUITE 200 SE DECISION MADE: 26-SEP-07
CLEVELAND, OH 44122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE LAPAROSCOPIC INSTRUMENT
MODERN MEDICAL EQUIPMENT MFG., LTD510(k) NO: K070812(SPECIAL)
ATTN: ROBERT STILLMAN PHONE NO : 804-353-7180
1705 DABNEY ROAD SE DECISION MADE: 14-SEP-07
RICHMOND, VA 23230 510(k) STATEMENT
DEVICE: BIOGEL ECLIPSE, LATEX, POWDER FREE, INDICATOR UNDERGLOVE WITH PR
MOLNLYCKE HEALTH CARE US, LLC 510(k) NO: K071414(TRADITIONAL)
ATTN: STEVEN DOWDLEY PHONE NO : 678-250-7930
5550 PEACHTREE PARKWAY SE DECISION MADE: 10-SEP-07
SUITE 500 510(k) SUMMARY AVAILABLE FROM FDA
NORCROSS, GA 30092
DEVICE: BIOGEL INDICATOR UNDERGLOVE WITH NON-PYROGENIC STATEMENT
MOLNLYCKE HEALTH CARE US, LLC 510(k) NO: K071565(TRADITIONAL)
ATTN: STEVEN DOWDLEY PHONE NO : 678-250-7930
5550 PEACHTREE PARKWAY SE DECISION MADE: 10-SEP-07
SUITE 500 510(k) SUMMARY AVAILABLE FROM FDA
NORCROSS, GA 30092
DEVICE: BIOGEL ORTHOPAEDIC SURGICAL GLOVE WITH NON-PRYOGENIC STATEMENT
MOLNLYCKE HEALTHCARE, US LLC 510(k) NO: K071465(TRADITIONAL)
ATTN: STEVEN DOWDLEY PHONE NO : 678-250-7930
5550 PEACHTREE PARKWAY SE DECISION MADE: 11-SEP-07
SUITE 500 510(k) SUMMARY AVAILABLE FROM FDA
NORCROSS, GA 30092
DEVICE: BIOGEL SENSOR SURGEON'S GLOVE WITH NON-PYROGENIC STATEMENT
MOLNLYCKE HEALTHCARE, US LLC 510(k) NO: K071700(TRADITIONAL)
ATTN: STEVEN DOWDLEY PHONE NO : 678-250-7930
5550 PEACHTREE PARKWAY SE DECISION MADE: 11-SEP-07
SUITE 500 510(k) SUMMARY AVAILABLE FROM FDA
NORCROSS, GA 30092
DEVICE: MONDEAL HAND CONTOUR SYSTEM
MONDEAL MEDICAL SYSTEMS GMBH 510(k) NO: K071797(TRADITIONAL)
ATTN: JAY EVANS PHONE NO : 858-901-4123
13566 FREEPORT ROAD SE DECISION MADE: 17-SEP-07
SAN DIEGO, CA 92133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONDEAL DISTAL RADIUS SYSTEM
MONDEAL MEDICAL SYSTEMS GMBH 510(k) NO: K071798(TRADITIONAL)
ATTN: JAY EVANS PHONE NO : 858-901-4123
13566 FREEPORT ROAD SE DECISION MADE: 17-SEP-07
SAN DIEGO, CA 92133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST
NANOSPHERE, INC 510(k) NO: K070804(TRADITIONAL)
ATTN: SUE KENT PHONE NO : 847-400-9000
4088 COMMERCIAL AVENUE SE DECISION MADE: 17-SEP-07
NORTHBROOK, IL 60062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR
NDO SURGICAL, INC. 510(k) NO: K071553(TRADITIONAL)
ATTN: JOHN J VOZELLA PHONE NO : 508-337-8881
125 HIGH ST., SE DECISION MADE: 18-SEP-07
SUITE 7 510(k) SUMMARY AVAILABLE FROM FDA
MANSFIELD, MA 02048
DEVICE: NEOPIP INFANT RESUSCITATOR
NEOFORCE GROUP, INC. 510(k) NO: K072021(TRADITIONAL)
ATTN: MONICA FERRANTE PHONE NO : 215-672-6800
35 COMMERCE DR. SE DECISION MADE: 12-SEP-07
IVYLAND, PA 18974 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO DBB-05 HEMODIALYSIS DELIVERY SYSTEM
NIKKISO CO. LTD. 510(k) NO: K061519(SPECIAL)
ATTN: FUMIAKI KANAI PHONE NO : 81 3 38188577
4-2-1 YUSHIMA SE DECISION MADE: 28-SEP-07
BUNKYO-KU 510(k) SUMMARY AVAILABLE FROM FDA
TOKYO, JAPAN 113-0034
DEVICE: NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLE
NIPRO MEDICAL CORPORATION 510(k) NO: K071145(ABBREVIATED)
ATTN: JESSICA OSWALD PHONE NO : 305-599-7174
3150 N.W. 107TH AVE. SE DECISION MADE: 07-SEP-07
MIAMI, FL 33172 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NES REPROCESSED ENDOSCOPIC TROCAR
NORTHEAST SCIENTIFIC, INC. 510(k) NO: K060676(TRADITIONAL)
ATTN: CRAIG ALLMENDINGER PHONE NO : 203-756-2111
29 SOUTH COMMONS ROAD SE DECISION MADE: 07-SEP-07
WATERBURY, CT 06704 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEUTROPHASE WOUND CLEANSER
NOVABAY PHARMACEUTICALS 510(k) NO: K071056(TRADITIONAL)
ATTN: LUANA STAIGER PHONE NO : 510-899-8852
5080 HORTON STREET SUITE 550 SE DECISION MADE: 28-SEP-07
EMERYVILLE, CA 94608 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPY FLUORESCENT IMAGING SYSTEM
NOVADAQ TECHNOLOGIES, INC. 510(k) NO: K072222(SPECIAL)
ATTN: ALLISON MANNERS PHONE NO : 905 629 3822
2585 SKYMARK AVENUE, STE. 306 SE DECISION MADE: 07-SEP-07
MISSISSAUGA, ONTARIO, CANADA L4W 4510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMER ACID DERIVED NANO-HYBRID COMPOSITE RESTORATIVE MATERIAL
NOVOCOL, INC. 510(k) NO: K072150(ABBREVIATED)
ATTN: STEVE RUDOLPH PHONE NO : 303-665-7535
416 SOUTH TAYLOR AVE. SE DECISION MADE: 13-SEP-07
LOUISVILLE, CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTEGRATED BRACHYTHERAPY UNIT - DIGITAL
NUCLETRON CORP. 510(k) NO: K072445(SPECIAL)
ATTN: LISA DIMMICK PHONE NO : 410-312-4435
8671 ROBERT FULTON DRIVE SE DECISION MADE: 14-SEP-07
COLUMBIA, MD 21046 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTIPLE BRAND MALE LATEX CONDOM
NULATEX SDN. BHD. 510(k) NO: K070937(ABBREVIATED)
ATTN: KIM L LEE PHONE NO : 607 777 1820
LOT 1870, 4TH MILES JALAN SE DECISION MADE: 21-SEP-07
MENGKIBOL 510(k) STATEMENT
KLUANG, JOHOR, MALAYSIA 86000
DEVICE: OLYMPUS CAPSULE ENDOSCOPE SYSTEM
OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K063259(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 484-896-5688
3500 CORPORATE PARKWAY SE DECISION MADE: 14-SEP-07
PO BOX 610 510(k) SUMMARY AVAILABLE FROM FDA
CENTER VALLEY, PA 18034-0610
DEVICE: OMNIWAVE ENDOVASCULAR SYSTEM
OMNISONICS MEDICAL TECHNOLOGIES 510(k) NO: K071762(TRADITIONAL)
ATTN: ANNE M KULIS PHONE NO : 978-657-9980
66 CONCORD STREET, SUITE A SE DECISION MADE: 27-SEP-07
WILMINGTON, MA 01887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CA, MODEL: CAM
OPTOVUE, INC. 510(k) NO: K071250(TRADITIONAL)
ATTN: JAY WEI PHONE NO : 510-623-8868
41752 CHRISTY STREET SE DECISION MADE: 28-SEP-07
FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMBRACE GEL
ORISON CORPORATION 510(k) NO: K072515(TRADITIONAL)
ATTN: AL SANDY PHONE NO : 423-282-5919
121 BOONE RIDGE DR. SE DECISION MADE: 20-SEP-07
JOHNSON CITY, TN 37601 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRAT
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K072440(SPECIAL)
ATTN: MARLENE HANNA PHONE NO : 585-453-4041
100 INDIGO CREEK DR. SE DECISION MADE: 20-SEP-07
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K072443(SPECIAL)
ATTN: MARLENE HANNA PHONE NO : 585-453-4041
100 INDIGO CREEK DR. SE DECISION MADE: 24-SEP-07
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NAVITRACK SYSTEM- PARTIAL HIP RESURFACING UNIVERSAL
ORTHOSOFT, INC. 510(k) NO: K071929(TRADITIONAL)
ATTN: CHRISTOPHER MCLEAN PHONE NO : 514 861 4074
75 QUEEN ST., SUITE 3300 SE DECISION MADE: 19-SEP-07
MONTREAL, QUEBEC, CANADA H3C 2N6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITOSS BIOACTIVE FOAM BONE GRAFT SUBSTITUTE
ORTHOVITA, INC. 510(k) NO: K072184(TRADITIONAL)
ATTN: GINA M NAGVAJARA PHONE NO : 610-407-5251
45 GREAT VALLEY PKWY. SE DECISION MADE: 18-SEP-07
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GS SYSTEM
OSSTEM IMPLANT CO.,LTD 510(k) NO: K063861(TRADITIONAL)
ATTN: CATHRYN N CAMBRIA PHONE NO : 770-396-5909
5536 TROWBRIDGE DRIVE SE DECISION MADE: 21-SEP-07
DUNWOODY, GA 30338 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C350 POWERED WHEELCHAIR
PERMOBIL AB 510(k) NO: K071650(TRADITIONAL)
ATTN: JAN ASTROM PHONE NO : 46 605 95959
BOX 120 SE DECISION MADE: 12-SEP-07
TIMRA, SWEDEN S-861 23 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHILIPS HEARTSTART 12 LEAD TRANSFER STATION, MODEL 989803142521
PHILIPS MEDICAL SYSTEMS, INC. 510(k) NO: K071391(TRADITIONAL)
ATTN: PAUL SCHRADER PHONE NO : 978-659-2404
3000 MINUTEMAN RD. SE DECISION MADE: 07-SEP-07
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHILIPS AVALON FETAL MONITORS FM20 AND FM30
PHILIPS MEDIZINSYSTEME BOEBLINGEN 510(k) NO: K071800(ABBREVIATED)
ATTN: MICHAEL ASMALSKY PHONE NO : 497 031 4631277
HEWLETT-PACKARD STR.2 SE DECISION MADE: 27-SEP-07
BOEBLINGEN, BADEN-WUERTTEMBERG, GE510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWRSYRINGE INJECTOR
PINYONS MEDICAL TECHNOLOGY, INC. 510(k) NO: K072318(TRADITIONAL)
ATTN: SHAWN P FOJTIK PHONE NO : 435-602-9640
5010 HEUGA CT. SE DECISION MADE: 21-SEP-07
PARK CITY, UT 84098 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: POWRSYRINGE MONITOR
PINYONS MEDICAL TECHNOLOGY, INC. 510(k) NO: K072345(TRADITIONAL)
ATTN: SHAWN P FOJTIK PHONE NO : 435-602-9640
5010 HEUGA CT. SE DECISION MADE: 21-SEP-07
PARK CITY, UT 84098 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PLANMECA PROONE
PLANMECA OY 510(k) NO: K072244(TRADITIONAL)
ATTN: LARS MORING PHONE NO : 358 207 795500
ASENTAJANKATU 6 SE DECISION MADE: 21-SEP-07
HELSINKI, FINLAND 00880 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PTS PANELS CHOL+HDL+GLU PANEL TEST STRIPS
POLYMER TECHNOLOGY SYSTEMS, INC. 510(k) NO: K071507(SPECIAL)
ATTN: MARGO ENRIGHT PHONE NO : 317-870-5610
7736 ZIONSVILLE RD. SE DECISION MADE: 10-SEP-07
INDIANAPOLIS, IN 46268 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL: 106552
POSSIS MEDICAL, INC. 510(k) NO: K072269(TRADITIONAL)
ATTN: MIKE BURNSIDE PHONE NO : 763-780-4555
9055 EVERGREEN BLVD., N.W. SE DECISION MADE: 08-SEP-07
MINNEAPOLIS, MN 55433-8003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: I45, I45S, I60, AND I60S
POWER MEDICAL INTERVENTIONS, INC. 510(k) NO: K071708(TRADITIONAL)
ATTN: BARBARA J WHITMAN PHONE NO : 267-775-8151
2021 CABOT BLVD. SE DECISION MADE: 27-SEP-07
LANGHORNE, PA 19047 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRESYM TRCG TRACHEOCARDIOGRAM, MODEL 112
PRESYM, INC. 510(k) NO: K063735(TRADITIONAL)
ATTN: TAMIM HAMID PHONE NO : 510-714-0525
15 TWELVE OAKS DRIVE SE DECISION MADE: 19-SEP-07
PLEASANTON, CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALWAYS MENSTRUAL PADS
PROCTER & GAMBLE, INC. 510(k) NO: K071827(TRADITIONAL)
ATTN: LENORE FAULHABER PHONE NO : 513-634-2466
6110 CENTER HILL AVENUE SE DECISION MADE: 20-SEP-07
CINCINNATI, OH 45224 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES
PULSION MEDICAL SYSTEMS AG 510(k) NO: K072364(SPECIAL)
ATTN: JAMIE SULLEY PHONE NO : 919-562-4851
7220 SPARHAWK RD. SE DECISION MADE: 19-SEP-07
WAKE FOREST, NC 27587 510(k) STATEMENT
DEVICE: DIODE MEDICAL LASER FAMILY, MODELS 4, 6, 30
QUANTA SYSTEM, S.P.A. 510(k) NO: K072034(TRADITIONAL)
ATTN: ISABELLA CARRER PHONE NO : 390 331 376797
VIA IV NOVEMBRE,116 SE DECISION MADE: 20-SEP-07
SOLBIATE OLONA(VA), ITALY 21058 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MODIFICATION TO RADIUS SNARE
RADIUS MEDICAL TECHNOLOGIES, INC. 510(k) NO: K071457(SPECIAL)
ATTN: MAUREEN FINLAYSON PHONE NO : 978-263-4466
15 CRAIG ROAD SE DECISION MADE: 25-SEP-07
ACTON, MA 01720 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COR ANALYZER II, MODEL V1.7
RCADIA MEDICAL IMAGING LTD. 510(k) NO: K072242(SPECIAL)
ATTN: DAN LAOR PHONE NO : 972 482 46632
6 SIRENI SE DECISION MADE: 11-SEP-07
HAIFA, ISRAEL 32972 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RELIANCE VBS SYSTEM
RELIANCE MEDICAL SYSTEMS, LLC 510(k) NO: K063637(TRADITIONAL)
ATTN: BRET M BERRY PHONE NO : 801-718-7467
1838 E 9800 SOUTH SE DECISION MADE: 27-SEP-07
SANDY, UT 84092 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RELIANCE S.E.P.
RELIANCE ORTHODONTIC PRODUCTS, INC510(k) NO: K071688(TRADITIONAL)
ATTN: PAUL GANGE PHONE NO : 630-773-4009
1540 WEST THORNDALE AVE. SE DECISION MADE: 07-SEP-07
ITASCA, IL 60143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTICHAMBER ADVANTAGE ANTI-STATIC VALVED HOLDING CHAMBER
RESPIRONICS NEW JERSEY, INC. 510(k) NO: K072418(TRADITIONAL)
ATTN: LAUREN ZIEGLER PHONE NO : 973-571-2600
41 CANFIELD RD. SE DECISION MADE: 12-SEP-07
CEDAR GROVE, NJ 07009 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: RT300-S, RT300-SP (PEDIATRIC VERSION), MODEL FA100052, FA100053
RESTORATIVE THERAPIES INC. 510(k) NO: K071486(SPECIAL)
ATTN: ANDREW BARRISKILL PHONE NO : 800-609-9166
907 SOUTH LAKEWOOD AVE. SE DECISION MADE: 10-SEP-07
BALTIMORE, MD 21224 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORTRAIT STAND-OFF
RHYTEC INCORPORATED 510(k) NO: K072394(SPECIAL)
ATTN: ROBERT ZOLETTI PHONE NO : 781-419-9482
130 TURNER STREET SE DECISION MADE: 12-SEP-07
BUILDING 2 510(k) SUMMARY AVAILABLE FROM FDA
WALTHAM, MA 02453
DEVICE: TOTAL PROTEIN URINE/CSF GEN.3
ROCHE DIAGNOSTICS 510(k) NO: K071239(SPECIAL)
ATTN: CORINA HARPER PHONE NO : 317-521-3831
9155 HAGUE RD. SE DECISION MADE: 14-SEP-07
PO BOX 50416 510(k) SUMMARY AVAILABLE FROM FDA
INDIANAPOLIS, IN 46250
DEVICE: ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620
ROCHE DIAGNOSTICS CORP. 510(k) NO: K071644(TRADITIONAL)
ATTN: DIMITRIS DEMIRTZOGLOU PHONE NO : 317-521-7688
9115 HAGUE RD. SE DECISION MADE: 12-SEP-07
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERPLATE INTERBODY FUSION DEVICE, MODELS C, CGC, L AND LGC
RSB SPINE LLC. 510(k) NO: K071922(TRADITIONAL)
ATTN: KAREN E WARDEN PHONE NO : 440-729-8457
8202 SHERMAN ROAD SE DECISION MADE: 18-SEP-07
CHESTERLAND, OH 44026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EYETRACKER/IDEAS
S.A. INSTRUMENTATION DIFRA 510(k) NO: K070670(TRADITIONAL)
ATTN: GUIDO PAGNACCO PHONE NO : 307-637-5711
205 CO. RD. 128A SE DECISION MADE: 18-SEP-07
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
CHEYENNE, WY 82007-1831
DEVICE: LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660
SAPI MED S.P.A 510(k) NO: K070881(TRADITIONAL)
ATTN: E.J. SMITH PHONE NO : 410-451-0639
1676 VILLAGE GREEN SUITE A SE DECISION MADE: 26-SEP-07
CROFTON, MD 21114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: I-SURGE
SATELEC 510(k) NO: K071965(TRADITIONAL)
ATTN: STEVE SALESKY PHONE NO : 800-289-6367
124 GAITHER DRIVE SE DECISION MADE: 10-SEP-07
SUITE 140 510(k) SUMMARY AVAILABLE FROM FDA
MT. LAUREL, NJ 08054
DEVICE: MINI LED AUTOFOCUS
SATELEC 510(k) NO: K072181(TRADITIONAL)
ATTN: STEVE SALESKY PHONE NO : 800-289-6367
124 GAITHER DRIVE SE DECISION MADE: 19-SEP-07
SUITE 140 510(k) SUMMARY AVAILABLE FROM FDA
MT. LAUREL, NJ 08054
DEVICE: STATIS DENTAL HANDPIECES
SCICAN LTD. 510(k) NO: K071891(ABBREVIATED)
ATTN: BRENDA MURPHY PHONE NO : 416 446 2797
1440 DON MILLS RD. SE DECISION MADE: 13-SEP-07
TORONTO, ONTARIO, CANADA M3B 3P9 510(k) STATEMENT
DEVICE: SENOSONIX ULTRASOUND BREAST BIOPSY SYSTEM
SENORX, INC. 510(k) NO: K072541(TRADITIONAL)
ATTN: PHONE NO :
11 COLUMBIA SE DECISION MADE: 25-SEP-07
ALISO VIEJO, CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SENTEC DIGITAL MONITORING SYSTEM
SENTEC AG 510(k) NO: K071672(TRADITIONAL)
ATTN: STEPHEN H GORSKI PHONE NO : 262-594-2114
S65 W35739 PIPER ROAD SE DECISION MADE: 12-SEP-07
EAGLE, WI 53119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DC-6 DIAGNOSTIC ULTRASOUND SYSTEM
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K072164(TRADITIONAL)
ATTN: LI DONGLING PHONE NO : 86 755 26582888
MINDRAY BUILDING, KEJI 12TH RD SE DECISION MADE: 05-SEP-07
SOUTH, HI-TECH INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA
NANSHAN,SHENZHEN, P.R. CHINA, CHINTHIRD PARTY REVIEW
DEVICE: RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER
SHL TELEMEDICINE INTERNATIONAL LTD510(k) NO: K063609(TRADITIONAL)
ATTN: GEORGE J HATTUB PHONE NO : 508-479-6116
291 HILLSIDE AVE. SE DECISION MADE: 12-SEP-07
SOMERSET, MA 02726 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K072392(SPECIAL)
ATTN: KIM RENDON PHONE NO : 610-448-1773
51 VALLEY STREAM PKWY. SE DECISION MADE: 25-SEP-07
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIEMENS DIAGNOSTIC ULTRASOUND SYSTEMS
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K072090(SPECIAL)
ATTN: KRISTEN DORROUGH PHONE NO : 650-943-7375
1230 SHOREBIRD WAY SE DECISION MADE: 14-SEP-07
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SBI TWISTOFIX
SMALL BONE INNOVATIONS INC. 510(k) NO: K071541(TRADITIONAL)
ATTN: ROBERT HOEHN PHONE NO : 212-583-0250
505 PARK AVE., 14TH FLOOR SE DECISION MADE: 10-SEP-07
NEW YORK, NY 10022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES, MAGENTA AND WHITE COLOR
SMART GLOVE CORP. SDN BHD 510(k) NO: K071170(TRADITIONAL)
ATTN: FOO KHON PU PHONE NO : 603 329 16100
LOT 6487 BATU 5 3/4 SE DECISION MADE: 14-SEP-07
JALAN KAPAR 510(k) SUMMARY AVAILABLE FROM FDA
KLANG SELANGOR, MALAYSIA 42100
DEVICE: CROSSLINKED POLYETHYLENE ARTICULAR INSERTS
SMITH & NEPHEW, INC. 510(k) NO: K071071(ABBREVIATED)
ATTN: RISHI SINHA PHONE NO : 901-399-6054
1450 E BROOKS ROAD SE DECISION MADE: 19-SEP-07
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS
SMITH & NEPHEW, INC. 510(k) NO: K072322(SPECIAL)
ATTN: JULIE ACKER PHONE NO : 508-261-3618
150 MINUTEMAN RD. SE DECISION MADE: 18-SEP-07
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DANA 3CC SYRINGE INSULIN RESERVOIR
SOOIL DEVELOPMENT CO., LTD. 510(k) NO: K071418(TRADITIONAL)
ATTN: CYNTHIA NOLTE, PH.D PHONE NO : 919-859-4207
49 PLAIN STREET SE DECISION MADE: 04-SEP-07
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: D131 PH.I.S.I.O DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRO
SORIN GROUP ITALIA S.R.L. 510(k) NO: K072308(SPECIAL)
ATTN: BARRY SALL PHONE NO : 781-434-4742
200 WEST STREET SE DECISION MADE: 12-SEP-07
WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEAR IMAGE ALIGNER
SPECIALTY APPLIANCE WORKS, INC. 510(k) NO: K071970(TRADITIONAL)
ATTN: JAMES W KOLKA PHONE NO : 770-977-4049
2193 SPEAR POINT DR. SE DECISION MADE: 25-SEP-07
MARIETTA, GA 30062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO SPINAL USA VBR SYSTEM
SPINAL USA 510(k) NO: K070922(TRADITIONAL)
ATTN: JEFFREY JOHNSON PHONE NO : 601-420-4244
644 LAKELAND EAST DR., STE. A SE DECISION MADE: 19-SEP-07
FLOWOOD, MS 39232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRK TRANSSEPTAL NEEDLE
ST. JUDE MEDICAL 510(k) NO: K072278(TRADITIONAL)
ATTN: LAURA MOEN-FTACEK PHONE NO : 952-933-4700
14901 DEVEAU PL. SE DECISION MADE: 13-SEP-07
MINNETONKA, MN 55345-2126 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MARROWMINER
STEMCOR SYSTEMS, INC. 510(k) NO: K071732(TRADITIONAL)
ATTN: SHARON ROCKWELL PHONE NO : 714-695-9269
5582 CHALON ROAD SE DECISION MADE: 24-SEP-07
YORBA LINDA, CA 92886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED ETHICON ETS ENDOSCOPIC LINEAR CUTTERS
STERILMED, INC. 510(k) NO: K070859(TRADITIONAL)
ATTN: CAROLINE BUTTERFIELD PHONE NO : 888-856-4870
11400 73RD AVE. NORTH SE DECISION MADE: 12-SEP-07
MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERIFY CHALLENGE PACKS, MODELS 270F 4 CHALLENGE PACK; 275F 3 CHA
STERIS CORPORATION 510(k) NO: K070895(ABBREVIATED)
ATTN: JOHN SCOVILLE PHONE NO : 440-392-7330
5960 HEISLEY RD. SE DECISION MADE: 05-SEP-07
MENTOR, OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: P.004 RC TEMPORARY ABUTMENT, P.004 TEMPORARY HEALING ABUTMENT (C
STRAUMANN MANUFACTURING, INC. 510(k) NO: K070478(TRADITIONAL)
ATTN: ELAINE ALAN PHONE NO : 978-747-2513
60 MINUTEMAN RD. SE DECISION MADE: 20-SEP-07
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: P.004 RC CARES TITANIUM AND CERAMIC ABUTMENTS
STRAUMANN USA 510(k) NO: K072151(TRADITIONAL)
ATTN: PAIGE SWEENEY PHONE NO : 800-448-8168
60 MINUTETEMAN ROAD SE DECISION MADE: 11-SEP-07
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: P.004 ABUTMENTS
STRAUMANN USA (ON BEHALF OF INSTIT510(k) NO: K071919(TRADITIONAL)
ATTN: PAIGE SWEENEY PHONE NO : 800-448-8168
60 MINUTEMAN ROAD SE DECISION MADE: 26-SEP-07
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER PEEK AND TITANIUM SOFT EYELET ANCHORS
STRYKER ENDOSCOPY 510(k) NO: K071157(TRADITIONAL)
ATTN: JEFF SEMONE PHONE NO : 408-754-2124
5900 OPTICAL CT. SE DECISION MADE: 17-SEP-07
SAN JOSE, CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER CROSSFIRE SYSTEM
STRYKER ENDOSCOPY 510(k) NO: K071859(TRADITIONAL)
ATTN: K. JEFFREY SEMONE PHONE NO : 408-754-2124
5900 OPTICAL CT. SE DECISION MADE: 20-SEP-07
SAN JOSE, CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEVILBISS INTELLIPAP MODEL DV 5 SERIES
SUNRISE MEDICAL 510(k) NO: K071689(TRADITIONAL)
ATTN: JOSEPH E OLSAVSKY PHONE NO : 814-443-7690
100 DEVILBISS DR. SE DECISION MADE: 07-SEP-07
SOMERSET, PA 15501 510(k) STATEMENT
DEVICE: QUICKIE QX MANUAL FOLDING WHEELCHAIR
SUNRISE MEDICAL, INC. 510(k) NO: K072153(TRADITIONAL)
ATTN: JOSEPH E OLSAVSKY PHONE NO : 814-443-7690
2842 BUSINESS PARK AVE. SE DECISION MADE: 10-SEP-07
FRESNO, CA 93727 510(k) STATEMENT
DEVICE: PERMA FACIAL IMPLANTS
SURGISIL 510(k) NO: K071823(TRADITIONAL)
ATTN: CYNTHIA J NOLTE PHONE NO : 508-643-0434
49 PLAIN ST. SE DECISION MADE: 19-SEP-07
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENSEAL TISSUE SEALING DEVICE
SURGRX INC 510(k) NO: K072493(SPECIAL)
ATTN: LINDA OLESON PHONE NO : 650-482-2400
101 SAGINAW DRIVE SE DECISION MADE: 27-SEP-07
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEM
SURGRX, INC. 510(k) NO: K072177(SPECIAL)
ATTN: LINDA OLESON PHONE NO : 650-482-2400
101 SAGINAW DR. SE DECISION MADE: 05-SEP-07
REDWOOD CITY, CA 94063 510(k) STATEMENT
DEVICE: FIXAFLOSS
SYBRON DENTAL SPECIALTIES, INC. 510(k) NO: K071615(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 W. COLLINS AVE. SE DECISION MADE: 21-SEP-07
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM MODIFICATIONS
SYNTHES (USA) 510(k) NO: K072095(TRADITIONAL)
ATTN: JILL SHERMAN PHONE NO : 610-719-6538
1301 GOSHEN PKWY. SE DECISION MADE: 27-SEP-07
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REVOLUTION TD-4229 BLOOD GLUCOSE MONITORING SYSTEM
TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K072489(SPECIAL)
ATTN: ERICA LI PHONE NO : 886 266 358080
4F, 88, SEC.1, KWANG FU ROAD SE DECISION MADE: 20-SEP-07
SAN CHUNG, TAIPEI, CHINA (TAIWAN) 510(k) STATEMENT
DEVICE: ALPHAONE BIOFEEDBACK SYSTEM
TELEDIAGNOSTIC SYSTEMS, INC. 510(k) NO: K071661(TRADITIONAL)
ATTN: LARRY WOODWARD PHONE NO : 650-625-9001
2484 OLD MIDDLEFIELD WAY SE DECISION MADE: 05-SEP-07
SUITE 202 510(k) STATEMENT
MOUNTAIN VIEW, CA 94043
DEVICE: POIINT OF CARE STRANDING SYSTEM, MODE 1004-00
THERAGENICS CORP. 510(k) NO: K072296(ABBREVIATED)
ATTN: BETSY CORTELLONI PHONE NO : 770-831-4294
5203 BRISTOL INDUSTRIAL WAY SE DECISION MADE: 26-SEP-07
BUFORD, GA 30518 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTR
THERMO ELECTRON OY 510(k) NO: K063838(TRADITIONAL)
ATTN: PAIVI SORMUNEN PHONE NO : 358 932 9100
RATASTIE 2 SE DECISION MADE: 27-SEP-07
VANTAA, FINLAND 01620 510(k) STATEMENT
DEVICE: ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL
THERMO FISHER SCIENTIFIC 510(k) NO: K070531(TRADITIONAL)
ATTN: BOLA NICHOLSON PHONE NO : 412-747-4039
171 INDUSTRY DRIVE SE DECISION MADE: 04-SEP-07
PITTSBURGH, PA 15275 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPI EASY 4.0 ABUTMENT
THOMMEN MEDICAL, AG 510(k) NO: K071453(SPECIAL)
ATTN: LINDA K SCHULZ PHONE NO : 858-792-1235
11234 EL CAMINO REAL, SE DECISION MADE: 19-SEP-07
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92130
DEVICE: TILITE AERO X
TISPORT, LLC 510(k) NO: K072311(ABBREVIATED)
ATTN: RICHARD S FORMAN PHONE NO : 509-586-6117
1426 EAST THIRD AVE. SE DECISION MADE: 21-SEP-07
KENNEWICK, WA 99337-9669 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRANS-CATHETER EXTRACTOR
TRAN PA-C, INC. 510(k) NO: K063048(TRADITIONAL)
ATTN: TOM TRAN PHONE NO : 321-276-5407
3348 HERRINGRIDGE DR. SE DECISION MADE: 14-SEP-07
ORLANDO, FL 32812 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KENDALL KERLIX ANTIMICROBIAL SUPER SPONGE DRESSING FOR OTC USE,
TYCO HEALTHCARE 510(k) NO: K070653(TRADITIONAL)
ATTN: PAUL W EVANS PHONE NO : 508-261-8203
15 HAMPSHIRE ST. SE DECISION MADE: 12-SEP-07
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KENDALL ANTIMICROBIAL DRAIN DRESSING FOR OTC USE, MODEL 6662
TYCO HEALTHCARE 510(k) NO: K070685(TRADITIONAL)
ATTN: PAUL W EVANS PHONE NO : 508-261-8203
15 HAMPSHIRE ST. SE DECISION MADE: 14-SEP-07
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UCP MULTIPLE DRUG SCREEN TEST CUPS
UCP BIOSCIENCES, INC. 510(k) NO: K072062(SPECIAL)
ATTN: NANCY CHEN PHONE NO : 408-392-0064
1445 KOLL CIRCLE, STE. 111 SE DECISION MADE: 20-SEP-07
SAN JOSE, CA 95112 510(k) STATEMENT
DEVICE: AUTOSUTURE ABSORBABLE TACK AND APPLICATOR
UNITED STATES SURGICAL, A DIVISION510(k) NO: K071920(TRADITIONAL)
ATTN: DANIEL CAMPION PHONE NO : 203-492-6339
150 GLOVER AVE. SE DECISION MADE: 28-SEP-07
NORWALK, CT 06856 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: USGI TRANSPORT ENDOSCOPIC ACCESS DEVICE
USGI MEDICAL 510(k) NO: K072405(SPECIAL)
ATTN: MARY LOU MOONEY PHONE NO : 949-369-3890
1140 CALLE CORDILLERA SE DECISION MADE: 13-SEP-07
SAN CLEMENTE, CA 92673 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QXT EXTRACTION CATHETER
VASCULAR SOLUTIONS, INC. 510(k) NO: K071727(TRADITIONAL)
ATTN: JULIE TAPPER PHONE NO : 763-656-4228
6464 SYCAMORE COURT NORTH SE DECISION MADE: 28-SEP-07
MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VECTEC DISPOSABLE TROCARS AND LAPAROSCOPIC ACCESSORIES
VECTEC 510(k) NO: K071976(TRADITIONAL)
ATTN: DIANE M HORWITZ PHONE NO : 703-242-0027
1220 NINETEENTH STREET; N.W. SE DECISION MADE: 06-SEP-07
SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20036
DEVICE: SPACER
VERICOM CO., LTD. 510(k) NO: K072069(TRADITIONAL)
ATTN: ALBERT REGO PHONE NO : 949-770-8710
27001 LA PAZ ROAD, SUITE 312 SE DECISION MADE: 28-SEP-07
MISSION VIEJO, CA 92691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENERAL SURGERY DRAPES
WELMED INC. 510(k) NO: K070432(TRADITIONAL)
ATTN: GLEN FEYE PHONE NO : 619-517-1762
1340 WEST PENNSYLVANIA AVENUE SE DECISION MADE: 24-SEP-07
SAN DIEGO, CA 92103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WU'S 4-WHEELED NEO SCOOTER, MODEL WT-M4A
WU'S TECH CO., LTD. 510(k) NO: K072337(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829
NO. 58 FU-CHIUN ST. SE DECISION MADE: 21-SEP-07
HSIN-CHU CITY, CHINA (TAIWAN) 3006510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAPLESS LI PEDICLE SCREW SYSTEM
X-SPINE SYSTEMS, INC. 510(k) NO: K072282(SPECIAL)
ATTN: DAVID KIRSCHMAN PHONE NO : 937-847-8400
452 ALEXANDERSVILLE RD. SE DECISION MADE: 14-SEP-07
MIAMISBURG, OH 45342 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED
ZIBO HONGYE SHANGQIN PLASTIC RUBBE510(k) NO: K072085(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 861 082 387441
RM 1606 BLDG.1. JIANXIANG YUAN SE DECISION MADE: 04-SEP-07
NO 209 BEI SI HUAN ZHONG ROA 510(k) SUMMARY AVAILABLE FROM FDA
BEIJING, CHINA 10083
DEVICE: ZIMMER PATIENT-SPECIFIC ABUTMENT, INTERNAL HEX, TITANIUM
ZIMMER DENTAL INC. 510(k) NO: K071439(TRADITIONAL)
ATTN: ERIN MCVEY PHONE NO : 760-929-4300
1900 ASTON AVE. SE DECISION MADE: 20-SEP-07
CARLSBAD, CA 92008-7308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ST360 SPINAL FIXATION SYSTEM, MODEL 07.0029-7500.5600
ZIMMER SPINE, INC. 510(k) NO: K072183(SPECIAL)
ATTN: TIM CRABTREE PHONE NO : 952-857-5631
7375 BUSH LAKE RD. SE DECISION MADE: 05-SEP-07
MINNEAPOLIS, MN 55439 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEXGEN TRABECULAR METAL TIBIAL TRAY
ZIMMER, INC. 510(k) NO: K072160(SPECIAL)
ATTN: BRANDON HIPSHER PHONE NO : 574-371-8083
P.O. BOX 708 SE DECISION MADE: 05-SEP-07
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEXGEN PROLONG ALL-POLY PATELLA
ZIMMER, INC. 510(k) NO: K072281(SPECIAL)
ATTN: BRANDON HIPSHER PHONE NO : 574-371-8083
P.O. BOX 708 SE DECISION MADE: 06-SEP-07
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 233
TOTAL WITH SUMMARIES 211
TOTAL WITH STATEMENTS 22
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