FDA 510(k) Application Details - K820729

Device Classification Name Pump, Blood, Cardiopulmonary Bypass, Roller Type

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510(K) Number K820729
Device Name Pump, Blood, Cardiopulmonary Bypass, Roller Type
Applicant 3M HEALTH CARE, SARNS

, US
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Regulation Number 870.4370

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Classification Product Code DWB
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Date Received 03/17/1982
Decision Date 11/01/1982
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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