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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 K140760
Device Name BONASTENT BILIARY
Applicant
ENDOCHOICE, INC.
1208-12 ROCKFORD RD.
TORONTO, ON,  CA M2R 3A2
Applicant Contact Bosmat Friedman
Correspondent
ENDOCHOICE, INC.
1208-12 ROCKFORD RD.
TORONTO, ON,  CA M2R 3A2
Correspondent Contact Bosmat Friedman
Regulation Number876.5010
Classification Product Code
FGE  
Date Received03/26/2014
Decision Date 06/16/2014
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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