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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 Dr.
Covington,  GA  30014
Applicant Contact CAROL VIERLING
Correspondent
C.R. Bard, Inc.
13183 Harland Dr.
Covington,  GA  30014
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
Predetermined Change
Control Plan Authorized		 No
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