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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 K901401
Device Name DAVOL AUTOTRANSFUSION BLOOD PROCESSING SYSTEM
Original Applicant
DAVOL, INC.
100 sockanossett crossroad
p.o. box 8500
cranston,  RI  02920
Original Contact annette m fagnant
Regulation Number868.5830
Classification Product Code
CAC  
Date Received03/26/1990
Decision Date 10/23/1990
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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