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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 K093003
Device Name BONASTENT BILIARY
Applicant
ENDOCHOICE, INC.
1914 J.N. PEASE PLACE
CHARLOTTE,  NC  28262
Applicant Contact SHOSHANA FRIEDMAN
Correspondent
ENDOCHOICE, INC.
1914 J.N. PEASE PLACE
CHARLOTTE,  NC  28262
Correspondent Contact SHOSHANA FRIEDMAN
Regulation Number876.5010
Classification Product Code
FGE  
Date Received09/28/2009
Decision Date 03/24/2010
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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