The following data is part of a premarket notification filed by Moria, Inc. with the FDA for One Up Disposable Keratome Head.
| Device ID | K981742 |
| 510k Number | K981742 |
| Device Name: | ONE UP DISPOSABLE KERATOME HEAD |
| Classification | Keratome, Ac-powered |
| Applicant | MORIA, INC. 15 RUE GEORGES BESSE Antony, FR 92160 |
| Contact | Alain Duprat |
| Correspondent | Alain Duprat MORIA, INC. 15 RUE GEORGES BESSE Antony, FR 92160 |
| Product Code | HNO |
| CFR Regulation Number | 886.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-18 |
| Decision Date | 1998-08-25 |
| Summary: | summary |