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FDA 510(k) Application Details - K053025
Device Classification Name
Tubing, Pump, Cardiopulmonary Bypass
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510(K) Number
K053025
Device Name
Tubing, Pump, Cardiopulmonary Bypass
Applicant
MAQUET CARDIOPULMONARY AG
P.O. BOX 2042
FAIRFIELD, IA 52556 US
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Contact
KATHLEEN JOHNSON
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Regulation Number
870.4390
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Classification Product Code
DWE
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More FDA Info for this Product Code
Date Received
10/27/2005
Decision Date
11/10/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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