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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 K024048
Device Name MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM
Applicant
Boston Scientific Scimed, Inc.
One Scimed Place
Maple Grove,  MN  55311
Applicant Contact TODD KORNMANN
Correspondent
Boston Scientific Scimed, Inc.
One Scimed Place
Maple Grove,  MN  55311
Correspondent Contact TODD KORNMANN
Regulation Number876.5010
Classification Product Code
FGE  
Date Received12/09/2002
Decision Date 01/06/2003
Decision SE - With Limitations (SESU)
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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