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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 K021630
Device Name BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM
Applicant
BOSTON SCIENTIFIC CORP.
ONE SCIMED PLACE
MAPLE GROVE,  MN  55311 -1566
Applicant Contact TODD KORNMANN
Correspondent
BOSTON SCIENTIFIC CORP.
ONE SCIMED PLACE
MAPLE GROVE,  MN  55311 -1566
Correspondent Contact TODD KORNMANN
Regulation Number876.5010
Classification Product Code
FGE  
Date Received05/17/2002
Decision Date 10/25/2002
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
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