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FDA 510(k) Application Details - K153143
Device Classification Name
Reservoir, Blood, Cardiopulmonary Bypass
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510(K) Number
K153143
Device Name
Reservoir, Blood, Cardiopulmonary Bypass
Applicant
Terumo Cardiovascular Systems Corporation
125 Blue Ball Road
Elkton, MD 21921 US
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Contact
Tierra A. Brown
Other 510(k) Applications for this Contact
Regulation Number
870.4400
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Classification Product Code
DTN
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More FDA Info for this Product Code
Date Received
10/30/2015
Decision Date
12/02/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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