The following data is part of a premarket notification filed by Epica International Inc. with the FDA for Seefactorct3.
| Device ID | K190856 |
| 510k Number | K190856 |
| Device Name: | SeeFactorCT3 |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | Epica International Inc. 2753 Camino Capistrano. Suite A-101 San Clemente, CA 92672 |
| Contact | Daniel Naimey |
| Correspondent | Frank Pokrop Frank Pokrop 3577 Sand Court Carlsbad, CA 92010 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-02 |
| Decision Date | 2019-09-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 86000594161101 | K190856 | 000 |
| 00860005941605 | K190856 | 000 |