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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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Applicant
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510(K)
Number
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Decision
Date
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zoll aed pro external defibrillator ZOLL MEDICAL CORPORATION k041892 02/04/2005
periarticular locking plates and screws, series 2358 and 2359 ZIMMER, INC. k043560 01/21/2005
modification to dynesys spinal system ZIMMER SPINE, INC k043565 03/11/2005
ncb plating system ZIMMER GMBH k042695 10/29/2004
sirus intramedullary nail-femoral and tibial nails, models 02.02631, 02.02651, 02.02652 series ZIMMER GMBH k043270 01/31/2005
hydrogum soft ZHERMACK S.P.A. k043118 01/24/2005
torpicalgin ZHERMACK S.P.A. k043131 12/15/2004
device modification of enteral feeding sets for gravity and pump use ZEVEX, INC. k012147 11/02/2001
multiple private labeled, non-sterile, powder-free, polyurethane white color, examination gloves (intacta polyurethane g YTY INDUSTRY (MANJUNG) SDN. BHD. k031384 06/17/2003
obtura gutta percha delivery system, model 823-700 YOUNG O/S LLC k042828 12/01/2004

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