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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 K012822
Device Name MODIFICIATION TO: BILIARY WALLSTENT ENDOPROSTHEIS WITH MONORAIL DELIVERY SYSTEM, MODEL 71-XXX
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 Received08/23/2001
Decision Date 10/24/2001
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
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