The following data is part of a premarket notification filed by Moria Sa with the FDA for Epi K Console.
| Device ID | K172994 |
| 510k Number | K172994 |
| Device Name: | EPI K Console |
| Classification | Keratome, Ac-powered |
| Applicant | Moria SA 15 Rue Georges Besse Antony, FR |
| Contact | Jean-paul Mercereau |
| Correspondent | Cherita James MSquared Association, Inc 901 King Street, Suite 200 Alexandria, VA 22314 |
| Product Code | HNO |
| CFR Regulation Number | 886.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-27 |
| Decision Date | 2017-10-26 |
| Summary: | summary |