The following data is part of a premarket notification filed by Oasis Medical, Inc. with the FDA for Disposable M2-pe Microkeratome Blades.
| Device ID | K030401 |
| 510k Number | K030401 |
| Device Name: | DISPOSABLE M2-PE MICROKERATOME BLADES |
| Classification | Keratome, Ac-powered |
| Applicant | OASIS MEDICAL, INC. 512 S. VERMONT AVE. Glendora, CA 91741 -6205 |
| Contact | Yvonne Fernandez |
| Correspondent | Yvonne Fernandez OASIS MEDICAL, INC. 512 S. VERMONT AVE. Glendora, CA 91741 -6205 |
| Product Code | HNO |
| CFR Regulation Number | 886.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-06 |
| Decision Date | 2003-06-19 |
| Summary: | summary |