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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 K101095
Device Name DIRECT PERORAL CHOLANGIOSCOPY BALLOON
Applicant
WILSON-COOK MEDICAL, INC.
4900 BETHANIA STATION ROAD
WINSTON SALEM,  NC 
Applicant Contact SCOTTIE FARIOLE
Correspondent
WILSON-COOK MEDICAL, INC.
4900 BETHANIA STATION ROAD
WINSTON SALEM,  NC 
Correspondent Contact SCOTTIE FARIOLE
Regulation Number876.5010
Classification Product Code
FGE  
Date Received04/20/2010
Decision Date 07/19/2010
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
Recalls CDRH Recalls
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