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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 K910991
Device Name SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM
Original Applicant
SHILEY, INC.
17600 gillette ave.
p.o. box 19503
irvine,  CA  92714
Original Contact allan abati
Regulation Number868.5830
Classification Product Code
CAC  
Date Received03/07/1991
Decision Date 11/27/1991
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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