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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stents, Drains And Dilators For The Biliary Ducts
510(k) Number K223469
Device Name WallFlex™ Biliary RX Stent System
Applicant
Boston Scientific Corporation
100 Boston Scientific Way
Marlboro,  MA  01752
Applicant Contact Alexis Erazo
Correspondent
Boston Scientific Corporation
200 Boston Scientific Way, Mail Stopm41
Marlborough,  MA  01752
Correspondent Contact Alexis Erazo
Regulation Number876.5010
Classification Product Code
FGE  
Date Received11/17/2022
Decision Date 06/15/2023
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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