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FDA 510(k) Application Details - K160884
Device Classification Name
Catheter, Continuous Flush
More FDA Info for this Device
510(K) Number
K160884
Device Name
Catheter, Continuous Flush
Applicant
COOK INCORPORATED
750 DANIELS WAY
BLOOMINGTON, IN 47404 US
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Contact
Daniel J. Corbin
Other 510(k) Applications for this Contact
Regulation Number
870.1210
More FDA Info for this Regulation Number
Classification Product Code
KRA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/31/2016
Decision Date
11/22/2016
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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