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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stent, ureteral
510(k) Number K162104
Device Name C-Flex Ureteral Stent Set
Applicant
COOK INCORPORATED
750 DANIELS WAY
BLOOMINGTON,  IN  47404
Applicant Contact MINJIN CHOI
Correspondent
COOK INCORPORATED
750 DANIELS WAY
BLOOMINGTON,  IN  47404
Correspondent Contact MINJIN CHOI
Regulation Number876.4620
Classification Product Code
FAD  
Date Received07/29/2016
Decision Date 04/24/2017
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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