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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
Applicant
DAVOL, INC.
100 SOCKANOSSETT CROSSROAD
P.O. BOX 8500
CRANSTON,  RI  02920
Applicant Contact ROBIN M DRAGO
Correspondent
DAVOL, INC.
100 SOCKANOSSETT CROSSROAD
P.O. BOX 8500
CRANSTON,  RI  02920
Correspondent 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 Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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