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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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sterile plate & screw kit configurations for use with the bioplate titanium fixation system BIOPLATE, INC. k022033 07/19/2002
osteomedics resorbable small fixation system, osteosorb OSTEOMEDICS, INC. k022035 01/17/2003
siemens virtual simulation (vsim) SIEMENS MEDICAL SOLUTIONS USA, INC. k022036 11/05/2002
xltek sleep system EXCEL TECH. LTD. k022037 09/10/2002
spi onetime dental implant PAXMED INTERNATIONAL k022038 07/15/2002
lyphochek whole blood control, models 561, 562, 563 BIO-RAD LABORATORIES, INC. k022041 07/16/2002
modification to cardeon ascending balloon cannula (abc) CARDEON CORP. k022042 09/03/2002
smart plug, model 500; smartplug forceps, model 502; push rod, model 503 MEDENNIUM, INC. k022043 10/18/2002
surgisis staple line reinforcement COOK BIOTECH, INC. k022044 08/23/2002
vitek gram positive susceptibility (gps) card for linezolid BIOMERIEUX, INC. k022045 08/15/2002

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