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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 K030645
Device Name BOSTON SCIENTIFIC EXPRESS BILIARY LD UNMOUNTED STENT
Applicant
Boston Scientific Corp
One Scimed Pl.
Maple Grove,  MN  55311
Applicant Contact TODD KORNMANN
Correspondent
Boston Scientific Corp
One Scimed Pl.
Maple Grove,  MN  55311
Correspondent Contact TODD KORNMANN
Regulation Number876.5010
Classification Product Code
FGE  
Date Received02/28/2003
Decision Date 03/25/2003
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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