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U.S. Department of Health and Human Services

510(K) Premarket Notification

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510(K)
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excelsior sl-10 microcatheter, models 168581, 168381, 168181, 168189 BOSTON SCIENTIFIC, TARGET k013789 12/06/2001
hemoglobin a1c reagent set TECO DIAGNOSTICS k051200 08/08/2005
hummer iv microdebrider system STRYKER INSTRUMENTS k011381 05/25/2001
modification to: restoration modular system HOWMEDICA OSTEONICS CORP. k050138 03/21/2005
burane xl WAVELIGHT LASER TECHNOLOGIE AG k050317 02/24/2005
stryker mmf screw STRYKER INSTRUMENTS k050535 03/17/2005
reso-pac periodontal dressing HAGER WORLDWIDE, INC. k050658 05/27/2005
reprocessed harmonic scalpels STERILMED, INC. k050343 04/12/2005
candela family of pulsed dye laser systems: pigmented lesion handpiece accessory CANDELA CORP. k051359 07/13/2005
twin power turbine high speed air turbine dental handpiece J. MORITA USA, INC. k043498 02/16/2005

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