The following data is part of a premarket notification filed by Endochoice, Inc. with the FDA for Bonastent Biliary.
| Device ID | K093003 |
| 510k Number | K093003 |
| Device Name: | BONASTENT BILIARY |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | ENDOCHOICE, INC. 1914 J.N. PEASE PLACE Charlotte, NC 28262 |
| Contact | Shoshana Friedman |
| Correspondent | Shoshana Friedman ENDOCHOICE, INC. 1914 J.N. PEASE PLACE Charlotte, NC 28262 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-28 |
| Decision Date | 2010-03-24 |
| Summary: | summary |