FDA 510(k) Application Details - K801360

Device Classification Name Defoamer, Cardiopulmonary Bypass

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510(K) Number K801360
Device Name Defoamer, Cardiopulmonary Bypass
Applicant TRAVENOL LABORATORIES, S.A.


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Regulation Number 870.4230

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Classification Product Code DTP
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Date Received 06/09/1980
Decision Date 07/14/1980
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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