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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 K171603
Device Name Cope Nephroureterostomy Stent and Amplatz Ureteral Stent Set
Applicant
Cook Incorporated
750 Daniels Way
Bloomington,  IN  47402
Applicant Contact Erum B. Nasir
Correspondent
Cook Incorporated
750 Daniels Way
Bloomington,  IN  47402
Correspondent Contact Erum B. Nasir
Regulation Number876.4620
Classification Product Code
FAD  
Date Received06/01/2017
Decision Date 04/16/2018
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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