The following data is part of a premarket notification filed by Endochoice, Inc. with the FDA for Bonastent Esophageal, Models Be And Ber, Bonastent Esophageal U.e.s. Flange And Flare, Models Befg And Befr.
| Device ID | K092144 |
| 510k Number | K092144 |
| Device Name: | BONASTENT ESOPHAGEAL, MODELS BE AND BER, BONASTENT ESOPHAGEAL U.E.S. FLANGE AND FLARE, MODELS BEFG AND BEFR |
| Classification | Prosthesis, Esophageal |
| 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 | ESW |
| CFR Regulation Number | 878.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-15 |
| Decision Date | 2010-02-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806369459105 | K092144 | 000 |
| 08806369458528 | K092144 | 000 |
| 08806369458542 | K092144 | 000 |
| 08806369458566 | K092144 | 000 |
| 08806369458580 | K092144 | 000 |
| 08806369458603 | K092144 | 000 |
| 08806369459006 | K092144 | 000 |
| 08806369459020 | K092144 | 000 |
| 08806369459044 | K092144 | 000 |
| 08806369459068 | K092144 | 000 |
| 08806369459082 | K092144 | 000 |
| 08806369458504 | K092144 | 000 |