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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 K963782
Device Name BARD MEMOTHERM TRANSHEPATIC BILIARY ENDOPROSTHESIS
Applicant
C.R. Bard, Inc.
13183 Harland Dr.
Covington,  GA  30014 -6421
Applicant Contact DONNA J WILSON
Correspondent
C.R. Bard, Inc.
13183 Harland Dr.
Covington,  GA  30014 -6421
Correspondent Contact DONNA J WILSON
Regulation Number876.5010
Classification Product Code
FGE  
Date Received09/20/1996
Decision Date 05/02/1997
Decision Substantially Equivalent (SESE)
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
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