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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 K000308
Device Name WALLSTENT BILIARY ENDOPROSTHESIS
Applicant
Boston Scientific Corp
One Boston Scientific Place
Natick,  MA  01760
Applicant Contact LISA M QUAGLIA
Correspondent
Boston Scientific Corp
One Boston Scientific Place
Natick,  MA  01760
Correspondent Contact LISA M QUAGLIA
Regulation Number876.5010
Classification Product Code
FGE  
Date Received02/01/2000
Decision Date 05/19/2000
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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