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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name defoamer, cardiopulmonary bypass
510(k) Number K823731
Device Name CARDF
Original Applicant
SHILEY, INC.
Regulation Number870.4230
Classification Product Code
DTP  
Date Received12/10/1982
Decision Date 01/05/1983
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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