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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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superdimension/bronchus premium SUPERDIMENSION, LTD. k052852 11/14/2005
modification to protege self-expanding nitinol stent with starport delivery technology SULZER INTRATHERAPEUTICS, INC. k014136 01/17/2002
versa-link porcelain bonding system SULTAN CHEMISTS, INC. k052699 11/16/2005
stryker spine avs asl peek spacer STRYKER SPINE k051205 11/04/2005
hipstar femoral stem STRYKER ORTHOPAEDICS k051223 05/10/2006
reprocessed deflectable electrophysiology diagnostic catheters STERILMED, INC. k051220 06/14/2005
stellartech coagulation system 2, models 1100c-115a and 1100c-230a STELLARTECH RESEARCH CORP. k050831 04/12/2005
socket graft STEINER LABORATORIES k052493 06/09/2006
thermal cautery probe STARION INSTRUMENTS k050308 02/25/2005
creatinine liquicolor STANBIO LABORATORY k050283 06/30/2005

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