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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 K931552
Device Name DAVOL CARDIOVASCULAR AUTOTRANSFUSION UNIT
Original Applicant
DAVOL, INC.
100 sockanossett crossroad
p.o. box 8500
cranston,  RI  02920
Original Contact robin m drago
Regulation Number868.5830
Classification Product Code
CAC  
Date Received03/29/1993
Decision Date 10/08/1993
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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