The following data is part of a premarket notification filed by Trophy with the FDA for Cs 9300, Cs 9300c.
| Device ID | K103659 |
| 510k Number | K103659 |
| Device Name: | CS 9300, CS 9300C |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | TROPHY 4 RUE F. PELLOUTIER CROISSY BEAUBOURG Marne La Vallee Cedex 2, FR 77437 |
| Contact | Marie-pierre Labat-camy |
| Correspondent | Marie-pierre Labat-camy TROPHY 4 RUE F. PELLOUTIER CROISSY BEAUBOURG Marne La Vallee Cedex 2, FR 77437 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-15 |
| Decision Date | 2011-08-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60192155319747 | K103659 | 000 |
| 60192155319730 | K103659 | 000 |
| 60192155319723 | K103659 | 000 |
| 60192155319716 | K103659 | 000 |
| 60192155319693 | K103659 | 000 |
| 60192155319686 | K103659 | 000 |