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FDA 510(k) Application Details - K191444
Device Classification Name
Oxygenator, Cardiopulmonary Bypass
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510(K) Number
K191444
Device Name
Oxygenator, Cardiopulmonary Bypass
Applicant
Medtronic, Inc.
7611 Northland Drive
Minneapolis, MN 55428 US
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Contact
Harsh Dharamshi
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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
05/31/2019
Decision Date
09/27/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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