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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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mdi scl-70 test MICRO DETECT, INC. k000934 04/07/2000
kfa-63 knee and foot array MRI DEVICES CORP. k000935 04/07/2000
sterltech water purifier STERLTECH, INC. k000941 04/06/2000
acticoat foam dressing WESTAIM BIOMEDICAL, INC. k000051 04/05/2000
insyte catheter, insyte autoguard catheter BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. k000235 04/05/2000
luxaform DMG USA, INC. k000951 04/05/2000
renaflo ii hf 2000 hemofilter MINNTECH CORP. k000028 04/04/2000
stela ut46 and bt45/46 straight tined pacing leads, stela uj45 and bj44/45 j-shaped tined pacing leads ELA MEDICAL, INC. k000029 04/04/2000
suni max SATELEC k000049 04/04/2000
medisul disposable vaginal speculum MARKETING PERSPECTIVES k000414 04/04/2000

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