The following data is part of a premarket notification filed by Moria S.a. with the FDA for Oneuse- Plus Microkeratome.
| Device ID | K040297 |
| 510k Number | K040297 |
| Device Name: | ONEUSE- PLUS MICROKERATOME |
| Classification | Keratome, Battery-powered |
| Applicant | MORIA S.A. 15 RUE GEORGES BESSE Antony, FR 92160 |
| Contact | Melanie Renaud-samiri |
| Correspondent | Melanie Renaud-samiri MORIA S.A. 15 RUE GEORGES BESSE Antony, FR 92160 |
| Product Code | HMY |
| CFR Regulation Number | 886.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-09 |
| Decision Date | 2004-03-31 |
| Summary: | summary |