The following data is part of a premarket notification filed by Trophy with the FDA for Cs Model+.
| Device ID | K193390 |
| 510k Number | K193390 |
| Device Name: | CS Model+ |
| Classification | Orthodontic Software |
| Applicant | Trophy 4 Rue F. Pelloutier Croissy-beaubourg, FR 77435 |
| Contact | Marie-pierre Labat-camy |
| Correspondent | Marie-pierre Labat-camy Trophy 4 Rue F. Pelloutier Croissy-beaubourg, FR 77435 |
| Product Code | PNN |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-06 |
| Decision Date | 2020-04-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60192155942716 | K193390 | 000 |
| 60192155944482 | K193390 | 000 |
| 00693856000302 | K193390 | 000 |