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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 K003793
Device Name BARD LUMINEXX BILIARY STENT
Applicant
C.R. Bard, Inc.
13183 Harland Dr.
Covington,  GA  30014 -6421
Applicant Contact CAROL VIERLING
Correspondent
C.R. Bard, Inc.
13183 Harland Dr.
Covington,  GA  30014 -6421
Correspondent Contact CAROL VIERLING
Regulation Number876.5010
Classification Product Code
FGE  
Date Received12/08/2000
Decision Date 01/05/2001
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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