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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 K993392
Device Name BARD MEMOTHERM FLEXX BILIARY STENT
Applicant
C.R. BARD, INC.
13183 HARLAND DRIVE
COVINGTON,  GA  30014 -6421
Applicant Contact CAROL VIERLING
Correspondent
C.R. BARD, INC.
13183 HARLAND DRIVE
COVINGTON,  GA  30014 -6421
Correspondent Contact CAROL VIERLING
Regulation Number876.5010
Classification Product Code
FGE  
Date Received10/08/1999
Decision Date 01/06/2000
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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