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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name apparatus, autotransfusion
510(k) Number K925827
Device Name IMPRAFLO(TM) POST OPERATIVE/DRAIN/REINFUS KIT/CANI
Original Applicant
IMPRA, INC.
1625 west 3rd st.
p.o. box 1740
tempe,  AZ  85281
Original Contact joseph j schwoebel
Regulation Number868.5830
Classification Product Code
CAC  
Date Received11/16/1992
Decision Date 07/29/1993
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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