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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 K831557
Device Name INTRAOPERATIVE AUTOTRANSFUSION SYS
Original Applicant
THORATEC LABORATORIES CORP.
Regulation Number868.5830
Classification Product Code
CAC  
Date Received05/16/1983
Decision Date 08/24/1983
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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