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U.S. Department of Health and Human Services

510(K) Premarket Notification
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510(K)
Number
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Decision
Date
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cryobag, model cb ORIGEN BIOMEDICAL, INC. k021702 08/06/2002
vaxcel picc with pasv valve technology CATHETER INNOVATIONS, INC. k021704 06/06/2002
modification to townley transfacepedicular screw fixation system MEDTRONIC SOFAMOR DANEK, INC. k021705 07/24/2002
horizons hot biopsy forceps HORIZONS INTL. CORP. k021706 06/21/2002
single step biopsy device, single step surgical handle, single step driver, single step holders SENORX, INC. k021707 08/14/2002
stat profile phox plus c analyzer NOVA BIOMEDICAL CORP. k021713 07/25/2002
rt-plus pe insert clamp PLUS ORTHOPEDICS k021714 06/21/2002
cemex rx, cemex isoplastic & cemex xl EXACTECH, INC. k021715 06/12/2002
simplify compact resuscitator POLYMED (XIAMEN) PLASTIC INDUSTRIAL CO.,LTD. k021716 10/08/2002
endoscopic light source, model xl300/l5 WORLD OF MEDICINE LEMKE GMBH k021717 08/20/2002

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