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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 K130792
Device Name LIFESTENT BILIARY STENT SYSTEM, LIFESTENT XL BILIARY STENT SYSTEM
Applicant
C.R. BARD, INC.
1625 WEST 3RD ST.
TEMPE,  AZ  85281 -1740
Applicant Contact Christoph Wagner von Hoff
Correspondent
C.R. BARD, INC.
1625 WEST 3RD ST.
TEMPE,  AZ  85281 -1740
Correspondent Contact Christoph Wagner von Hoff
Regulation Number876.5010
Classification Product Code
FGE  
Date Received03/22/2013
Decision Date 08/30/2013
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
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