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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 K110122
Device Name MUSTANG BALLOON DILATAION CATHETERS
Applicant
BOSTON SCIENTIFIC
ONE SCIMED PLACE
MAPLE GROVE,  MN  55311 -1566
Applicant Contact ANNE V ROSSI
Correspondent
BOSTON SCIENTIFIC
ONE SCIMED PLACE
MAPLE GROVE,  MN  55311 -1566
Correspondent Contact ANNE V ROSSI
Regulation Number876.5010
Classification Product Code
FGE  
Date Received01/18/2011
Decision Date 05/12/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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