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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 K112701
Device Name CHARGER BALLOON DILATATION CATHETER
Applicant
BOSTON SCIENTIFIC
ONE SCIMED PLACE
MAPLE GROVE,  MN  55311 -1566
Applicant Contact GLENN JACQUES
Correspondent
BOSTON SCIENTIFIC
ONE SCIMED PLACE
MAPLE GROVE,  MN  55311 -1566
Correspondent Contact GLENN JACQUES
Regulation Number876.5010
Classification Product Code
FGE  
Date Received09/16/2011
Decision Date 10/25/2011
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
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