The following data is part of a premarket notification filed by Trophy Radiologie with the FDA for Trophy Compact - Dental Unit.
| Device ID | K851136 |
| 510k Number | K851136 |
| Device Name: | TROPHY COMPACT - DENTAL UNIT |
| Classification | Unit, Operative Dental |
| Applicant | TROPHY RADIOLOGIE 106, RUE DE LA JARRY B.P. 20 Vincennes, Cedex (paris), FR 94307 |
| Contact | Sy Sevestre |
| Correspondent | Sy 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 | 1985-03-21 |
| Decision Date | 1985-07-31 |