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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)
Number
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Decision
Date
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ez-stik electrodes NAIMCO, INC. k050469 05/13/2005
endomark sterile india ink PMT CORP. k042901 03/16/2005
retractofoam COLTENE/WHALEDENT AG k050013 02/09/2005
oec olympus fluoroscopic imaging system GE OEC MEDICAL SYSTEMS, INC. k041932 08/18/2004
ge signa excite mr surgical option GE HEALTHCARE k043262 01/12/2005
biocardia morph universal deflectable guide catheter BIOCARDIA, INC. k042553 02/17/2005
auto therm 390, model me 390 METTLER ELECTRONICS CORP. k042554 10/08/2004
ligasure vessel sealing system. ligasure instruments VALLEYLAB k043273 01/05/2005
olsen medical anterior cervical vertebrae plate system OLSEN MEDICAL k042073 02/07/2005
press tack needle ASIA-MED GMBH & CO. KG. - WERK SUHL k042063 10/14/2004

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