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FDA 510(k) Application Details - K151349
Device Classification Name
Console, Heart-Lung Machine, Cardiopulmonary Bypass
More FDA Info for this Device
510(K) Number
K151349
Device Name
Console, Heart-Lung Machine, Cardiopulmonary Bypass
Applicant
Terumo Cardiovascular Systems Corporation
6200 Jackson Road
Ann Arbor, MI 48103 US
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Contact
John Chesney
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Regulation Number
870.4220
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Classification Product Code
DTQ
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More FDA Info for this Product Code
Date Received
05/20/2015
Decision Date
08/27/2015
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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