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FDA 510(k) Application Details - K022115
Device Classification Name
Oxygenator, Cardiopulmonary Bypass
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510(K) Number
K022115
Device Name
Oxygenator, Cardiopulmonary Bypass
Applicant
TERUMO CORP.
125 BLUE BALL RD.
ELKTON, MD 21921 US
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Contact
GARRY A COURTNEY
Other 510(k) Applications for this Contact
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
07/01/2002
Decision Date
09/27/2002
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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