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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 K191446
Device Name Ureteral Stent Systems, Biliary Drainage Catheters
Applicant
Boston Scientific Corporation
300 Boston Scientific Way
Marlborough,  MA  01752
Applicant Contact Jois Zuniga Gamboa
Correspondent
Boston Scientific Corporation
300 Boston Scientific Way
Marlborough,  MA  01752
Correspondent Contact Jois Zuniga Gamboa
Regulation Number876.4620
Classification Product Code
FAD  
Subsequent Product Code
FGE  
Date Received05/31/2019
Decision Date 01/02/2020
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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