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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name filter, blood, cardiopulmonary bypass, arterial line
510(k) Number K090518
Device Name QUART ARTERIAL FILTER WITH SOFTLINE COATING
Original Applicant
MAQUET CARDIOPULMONARY AG
hechinger strasse 38
hirrlingen,  GM 72145
Original Contact ingrid richter
Regulation Number870.4260
Classification Product Code
DTM  
Date Received02/26/2009
Decision Date 12/18/2009
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product Yes
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