FDA 510(k) Application Details - K760894

Device Classification Name Suction Control, Intracardiac, Cardiopulmonary Bypass

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510(K) Number K760894
Device Name Suction Control, Intracardiac, Cardiopulmonary Bypass
Applicant DELTA MEDICAL INDUSTRIES

, US
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Regulation Number 870.4430

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Classification Product Code DWD
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Date Received 10/26/1976
Decision Date 12/09/1976
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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