The following data is part of a premarket notification filed by Trophy Radiologie with the FDA for Trophy Radiologie Rvg Radiovisiography.
Device ID | K950533 |
510k Number | K950533 |
Device Name: | TROPHY RADIOLOGIE RVG RADIOVISIOGRAPHY |
Classification | Unit, X-ray, Intraoral |
Applicant | TROPHY RADIOLOGIE 106, RUE DE LA JARRY B.P. 20 Vincennes, Cedex (paris), FR 94307 |
Contact | Marie P Labat-camy |
Correspondent | Marie P Labat-camy TROPHY RADIOLOGIE 106, RUE DE LA JARRY B.P. 20 Vincennes, Cedex (paris), FR 94307 |
Product Code | EAP |
CFR Regulation Number | 872.1810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-02-03 |
Decision Date | 1995-06-30 |