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FDA 510(k) Application Details - K964967
Device Classification Name
Oxygenator, Cardiopulmonary Bypass
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510(K) Number
K964967
Device Name
Oxygenator, Cardiopulmonary Bypass
Applicant
MINNTECH CORP.
14605 28TH AVE. NORTH
MINNEAPOLIS, MN 55447 US
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Contact
RICHARD GOLDHABER
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Regulation Number
870.4350
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Classification Product Code
DTZ
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More FDA Info for this Product Code
Date Received
12/10/1996
Decision Date
03/06/1997
Decision
SESE - SUBST EQUIV
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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