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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 K832811
Device Name SHILEY 3L CARDF PLUS
Original Applicant
SHILEY, INC.
Regulation Number870.4230
Classification Product Code
DTP  
Date Received08/18/1983
Decision Date 09/20/1983
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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