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FDA 510(k) Application Details - K011804
Device Classification Name
Filter, Blood, Cardiopulmonary Bypass, Arterial Line
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510(K) Number
K011804
Device Name
Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Applicant
TERUMO CARDIOVASCULAR SYSTEMS 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
870.4260
More FDA Info for this Regulation Number
Classification Product Code
DTM
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More FDA Info for this Product Code
Date Received
06/11/2001
Decision Date
07/09/2001
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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