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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 K031186
Device Name LUMINEXX ENDOSCOPIC BILIARY STENT
Applicant
C.R. Bard, Inc.
129 Concord Rd.
Bldg. #3
Billerica,  MA  01821
Applicant Contact THOMAS HIRTE
Correspondent
C.R. Bard, Inc.
129 Concord Rd.
Bldg. #3
Billerica,  MA  01821
Correspondent Contact THOMAS HIRTE
Regulation Number876.5010
Classification Product Code
FGE  
Date Received04/15/2003
Decision Date 05/06/2003
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
Recalls CDRH Recalls
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