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FDA 510(k) Application Details - K971877
Device Classification Name
Oxygenator, Cardiopulmonary Bypass
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510(K) Number
K971877
Device Name
Oxygenator, Cardiopulmonary Bypass
Applicant
DIDECO S.P.A.
1601 TRAPELO RD.
WALTHAM, MA 02154 US
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Contact
BARRY SALL
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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
05/21/1997
Decision Date
10/08/1997
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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