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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, ureteral, gastro-urology
510(k) Number K182695
Device Name Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter
Cook Incorporated
750 Daniels Way
Bloomington,  IN  47404
Applicant Contact Chelsea Woods
Cook Incorporated
750 Daniels Way
Bloomington,  IN  47404
Correspondent Contact Chelsea Woods
Regulation Number876.5130
Classification Product Code
Date Received09/27/2018
Decision Date 06/17/2019
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