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FDA 510(k) Application Details - K100278
Device Classification Name
Oxygenator, Cardiopulmonary Bypass
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510(K) Number
K100278
Device Name
Oxygenator, Cardiopulmonary Bypass
Applicant
MAQUET CARDIOPULMONARY AG
HECHINGER STRASSE 38
HIRRLINGEN 72145 DE
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Contact
KATRIN SCHWENKGLENKS
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Regulation Number
870.4350
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Classification Product Code
DTZ
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Date Received
02/01/2010
Decision Date
04/30/2010
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
N
Expedited Review
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