FDA 510(k) Application Details - K912915

Device Classification Name Defoamer, Cardiopulmonary Bypass

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510(K) Number K912915
Device Name Defoamer, Cardiopulmonary Bypass
Applicant 3M HEALTH CARE, LTD.
6200 JACKSON RD.
P.O. BOX 1247
ANN ARBOR, MI US
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Contact CATHY L SIMPSON
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Regulation Number 870.4230

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Classification Product Code DTP
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Date Received 07/03/1991
Decision Date 09/25/1991
Decision SE - Substantially Equivalent
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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