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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 K063532
Device Name BARD E LUMINEXX BILIARY STENT
Applicant
Bard Peripheral Vascular, Inc.
P.O. Box 1740
Tempe,  AZ  85280 -1740
Applicant Contact LINDSAY K PACK
Correspondent
Bard Peripheral Vascular, Inc.
P.O. Box 1740
Tempe,  AZ  85280 -1740
Correspondent Contact LINDSAY K PACK
Regulation Number876.5010
Classification Product Code
FGE  
Date Received11/22/2006
Decision Date 05/30/2008
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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