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U.S. Department of Health and Human Services

510(K) Premarket Notification

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Device Name
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510(K)
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trident porous titanium acetabular component with peri-apatite coating HOWMEDICA OSTEONICS CORP. k013475 12/20/2001
synthes lcp distal tibia plates SYNTHES (USA) k013248 12/19/2001
pre-loaded ultrafix rc LINVATEC CORP. k013553 12/19/2001
auto suture surgical staples UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC k013860 12/19/2001
codman slim-loc system Codman & Shurtleff, Inc. k013877 12/19/2001
phoenoix ise reagents for roche hitachi, models 700/900 series PHOENIX DIAGNOSTICS, INC. k013451 12/18/2001
ethanol ABBOTT LABORATORIES k013538 12/14/2001
shoulder coil USA INSTRUMENTS, INC. k013541 12/14/2001
convoy advanced delivery sheath kit BOSTON SCIENTIFIC k013866 12/14/2001
amsco harmony surgical lighting and media system STERIS Corporation k013242 12/13/2001

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