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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 K020682
Device Name BARD LUMINEXX 6 FR BILIARY STENT AND DELIVERY SYSTEM
Applicant
C.R. BARD, INC.
13183 HARLAND DRIVE
COVINGTON,  GA  30014 -6421
Applicant Contact CAROL VIERLING
Correspondent
C.R. BARD, INC.
13183 HARLAND DRIVE
COVINGTON,  GA  30014 -6421
Correspondent Contact CAROL VIERLING
Regulation Number876.5010
Classification Product Code
FGE  
Date Received03/04/2002
Decision Date 04/02/2002
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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