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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 K141335
Device Name EXPEL APD DRAINAGE CATHETER SYSTEM
Applicant
Boston Scientific Corp
One Scimed Place
Maple Grove,  MN  55311 -1566
Applicant Contact MATT BEAUCHANE
Correspondent
Boston Scientific Corp
One Scimed Place
Maple Grove,  MN  55311 -1566
Correspondent Contact MATT BEAUCHANE
Regulation Number876.5010
Classification Product Code
FGE  
Date Received05/21/2014
Decision Date 10/17/2014
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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