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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 K993232
Device Name WALLSTENT BILIARY ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM
Applicant
Boston Scientific Scimed, Inc.
5905 Nathan Ln.
Plymouth,  MN  55442
Applicant Contact RONALD W BENNETT
Correspondent
Boston Scientific Scimed, Inc.
5905 Nathan Ln.
Plymouth,  MN  55442
Correspondent Contact RONALD W BENNETT
Regulation Number876.5010
Classification Product Code
FGE  
Date Received09/27/1999
Decision Date 12/30/1999
Decision SE - With Limitations (SESU)
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
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