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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 K133700
Device Name ADVANIX PANCREATIC STENT AND NAVIFLEX RAPID EXCHANGE PANCREATIC DELIVERY SYSTEM AND PUSHERS
Applicant
Boston Scientific Corporation
100 Boston Scientific Way
Marlboro,  MA  01752
Applicant Contact ELENA NIEVES
Correspondent
Boston Scientific Corporation
100 Boston Scientific Way
Marlboro,  MA  01752
Correspondent Contact ELENA NIEVES
Regulation Number876.5010
Classification Product Code
FGE  
Date Received12/03/2013
Decision Date 05/14/2014
Decision Substantially Equivalent (SESE)
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
Recalls CDRH Recalls
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