FDA 510(k) Application Details - K823731

Device Classification Name Defoamer, Cardiopulmonary Bypass

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510(K) Number K823731
Device Name Defoamer, Cardiopulmonary Bypass
Applicant SHILEY, INC.

, US
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Regulation Number 870.4230

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Classification Product Code DTP
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Date Received 12/10/1982
Decision Date 01/05/1983
Decision SE - Substantially Equivalent
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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