The following data is part of a premarket notification filed by Trophy Radiologie with the FDA for 70-x/rvg (radiovisiography).
Device ID | K881133 |
510k Number | K881133 |
Device Name: | 70-X/RVG (RADIOVISIOGRAPHY) |
Classification | Bar, Preformed |
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 | EHO |
CFR Regulation Number | 872.3165 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-03-16 |
Decision Date | 1989-07-20 |