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FDA 510(k) Application Details - K172984
Device Classification Name
Oxygenator, Cardiopulmonary Bypass
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510(K) Number
K172984
Device Name
Oxygenator, Cardiopulmonary Bypass
Applicant
Medtronic, Inc.
8200 Coral Sea Street NE
Mounds View, MN 55112 US
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Contact
Lisa Stone
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Regulation Number
870.4350
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Classification Product Code
DTZ
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More FDA Info for this Product Code
Date Received
09/27/2017
Decision Date
11/20/2017
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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