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510(k) K102109

ADVANCED MEMBRANE GAS EXCHANGE (AMG), AMG OXYGENALING MODULE, AMG VENOUS CARDIOTOMY RESEVOIR 4500 MODEL EU5011, EU5012 by Eurosets Srl — Product Code DTZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 2011
Date Received
July 28, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oxygenator, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4350
Review Panel
CV
Submission Type

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