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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 K003186
Device Name BARD MEMOTHERM ENDOSCOPIC BILIARY STENT
Applicant
C.R. BARD, INC.
129 CONCORD RD.
BILLERICA,  MA  01821
Applicant Contact BETH A ZIS
Correspondent
C.R. BARD, INC.
129 CONCORD RD.
BILLERICA,  MA  01821
Correspondent Contact BETH A ZIS
Regulation Number876.5010
Classification Product Code
FGE  
Date Received10/11/2000
Decision Date 01/09/2001
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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