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FDA 510(k) Application Details - K180557
Device Classification Name
Stent, Ureteral
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510(K) Number
K180557
Device Name
Stent, Ureteral
Applicant
Cook Incorporated
750 Daniels Way
Bloomington, IN 47404 US
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Contact
Yuan Zhou
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Regulation Number
876.4620
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Classification Product Code
FAD
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More FDA Info for this Product Code
Date Received
03/01/2018
Decision Date
11/23/2018
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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