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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 K101786
Device Name ADVANIX DOUBLE PIGTAIL BILIARY STENT
Applicant
Boston Scientific Corp
100 Boston Scientific Way
Marborough,  MA  01752
Applicant Contact ELENA NIEVES
Correspondent
Boston Scientific Corp
100 Boston Scientific Way
Marborough,  MA  01752
Correspondent Contact ELENA NIEVES
Regulation Number876.5010
Classification Product Code
FGE  
Date Received06/25/2010
Decision Date 07/23/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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