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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 K920361
Device Name BARD BILIARY BALLOON DILATORS
Applicant
C.R. BARD, INC.
1200 TECHNOLOGY PARK DR.
P.O. BOX 7025
BILLERICA,  MA  01821
Applicant Contact ERNEST MANFREDO
Correspondent
C.R. BARD, INC.
1200 TECHNOLOGY PARK DR.
P.O. BOX 7025
BILLERICA,  MA  01821
Correspondent Contact ERNEST MANFREDO
Regulation Number876.5010
Classification Product Code
FGE  
Date Received01/27/1992
Decision Date 11/24/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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