The following data is part of a premarket notification filed by Trophy with the FDA for Kodak 9000c Extraoral Imaging System.
| Device ID | K080889 |
| 510k Number | K080889 |
| Device Name: | KODAK 9000C EXTRAORAL IMAGING SYSTEM |
| Classification | System, X-ray, Extraoral Source, Digital |
| 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 | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-31 |
| Decision Date | 2008-04-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60192155211010 | K080889 | 000 |