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FDA 510(k) Application Details - K151051
Device Classification Name
Stent, Ureteral
More FDA Info for this Device
510(K) Number
K151051
Device Name
Stent, Ureteral
Applicant
COOK INCORPORATED
750 DANIELS WAY
BLOOMINGTON, IN 47404 US
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Contact
Jamie Ridner
Other 510(k) Applications for this Contact
Regulation Number
876.4620
More FDA Info for this Regulation Number
Classification Product Code
FAD
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More FDA Info for this Product Code
Date Received
04/20/2015
Decision Date
01/11/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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