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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 K012216
Device Name NIROYAL BILIARY PREMOUNTED STENT SYSTEM
Applicant
BOSTON SCIENTIFIC SCIMED, INC.
ONE SCIMED PLACE
MAPLE GROVE,  MN  55311 -1566
Applicant Contact CANDICE BURNS
Correspondent
BOSTON SCIENTIFIC SCIMED, INC.
ONE SCIMED PLACE
MAPLE GROVE,  MN  55311 -1566
Correspondent Contact CANDICE BURNS
Regulation Number876.5010
Classification Product Code
FGE  
Date Received07/16/2001
Decision Date 08/17/2001
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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