FDA 510(k) Application Details - K872167

Device Classification Name Defoamer, Cardiopulmonary Bypass

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510(K) Number K872167
Device Name Defoamer, Cardiopulmonary Bypass
Applicant AMERICAN BENTLEY
17502 ARMSTRONG AVE.
IRVINE, CA US
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Contact DONALD A RAIBLE
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Regulation Number 870.4230

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Classification Product Code DTP
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Date Received 06/08/1987
Decision Date 09/01/1987
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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