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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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scaphix, staple, fixation, bone AVANTA ORTHOPAEDICS, INC. k003033 05/30/2001
biosling - bioabsorbable polymer sling & surgical mesh INJECTX, INC. k010533 05/24/2001
pelvex hometrainer PURDUE TECHNOLOGY PARK k002043 05/21/2001
lifecore biomedical dental implant systems LIFECORE BIOMEDICAL, INC. k002037 05/16/2001
bioknotless anchor MITEK PRODUCTS k002639 05/11/2001
cardiac function laboratory; pressure interface; pressure / volume catheter CD LEYCOM BV k003020 05/11/2001
surgical titanium mesh system DEPUY ACROMED k003043 05/08/2001
cobe hc 700 midi hemoconcentrator HOSPAL INDUSTRIE k003023 04/30/2001
atrium medical corporation clearway ptfe balloon catheter ATRIUM MEDICAL CORP. k002627 04/26/2001
osi medical dolphin stand-alone pulse oximeter, model 2100 and digital dolphin optical sensor, clip-on finger probe, mod OSI MEDICAL, INC. k002036 04/17/2001

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