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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 K993892
Device Name DURAGLIDE STONE REMOVAL BALLOON, MODEL 000635-38, 000646-47, DURAGLIDE STONE BALLOON, MODEL 007124-25,007144-45
Applicant
C.R. Bard, Inc.
129 Concord Rd.
Bldg. #3
Billerica,  MA  01821
Applicant Contact MARION GORDON
Correspondent
C.R. Bard, Inc.
129 Concord Rd.
Bldg. #3
Billerica,  MA  01821
Correspondent Contact MARION GORDON
Regulation Number876.5010
Classification Product Code
FGE  
Date Received11/16/1999
Decision Date 01/06/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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