FDA 510(k) Application Details - K990514

Device Classification Name Defoamer, Cardiopulmonary Bypass

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510(K) Number K990514
Device Name Defoamer, Cardiopulmonary Bypass
Applicant C.R. BARD, INC.
25 COMPUTER DR.
HAVERHILL, MA 01832 US
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Contact SANDRA PERREAND
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Regulation Number 870.4230

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Classification Product Code DTP
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Date Received 02/18/1999
Decision Date 03/09/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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