The following data is part of a premarket notification filed by Trophy Radiologie with the FDA for Stomavision (stv).
| Device ID | K913464 |
| 510k Number | K913464 |
| Device Name: | STOMAVISION (STV) |
| Classification | Unit, Operative Dental |
| Applicant | TROPHY RADIOLOGIE 106, RUE DE LA JARRY B.P. 20 Vincennes, Cedex (paris), FR 94307 |
| Contact | Jy Sevestre |
| Correspondent | Jy Sevestre TROPHY RADIOLOGIE 106, RUE DE LA JARRY B.P. 20 Vincennes, Cedex (paris), FR 94307 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-05 |
| Decision Date | 1991-11-13 |