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 |