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 |