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FDA 510(k) Application Details - K013915
Device Classification Name
Oxygenator, Cardiopulmonary Bypass
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510(K) Number
K013915
Device Name
Oxygenator, Cardiopulmonary Bypass
Applicant
DIDECO S.P.A.
14401 WEST 65TH WAY
ARVADA, CO 80004-3599 US
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Contact
SHAWN RIEDEL
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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
11/27/2001
Decision Date
12/27/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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