BONASTENT BILIARY

Stents, Drains And Dilators For The Biliary Ducts

ENDOCHOICE, INC.

The following data is part of a premarket notification filed by Endochoice, Inc. with the FDA for Bonastent Biliary.

Pre-market Notification Details

Device IDK093003
510k NumberK093003
Device Name:BONASTENT BILIARY
ClassificationStents, Drains And Dilators For The Biliary Ducts
Applicant ENDOCHOICE, INC. 1914 J.N. PEASE PLACE Charlotte,  NC  28262
ContactShoshana Friedman
CorrespondentShoshana Friedman
ENDOCHOICE, INC. 1914 J.N. PEASE PLACE Charlotte,  NC  28262
Product CodeFGE  
CFR Regulation Number876.5010 [🔎]
DecisionSe - With Limitations (SESU)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-09-28
Decision Date2010-03-24
Summary:summary

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