K030401 is an FDA 510(k) clearance for the DISPOSABLE M2-PE MICROKERATOME BLADES. This device is classified as a Keratome, Ac-powered (Class I - General Controls, product code HNO).
Submitted by Oasis Medical, Inc. (Glendora, US). The FDA issued a Cleared decision on June 19, 2003, 133 days after receiving the submission on February 6, 2003.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4370.
| 510(k) Number | K030401 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 06, 2003 |
| Decision Date | June 19, 2003 |
| Days to Decision | 133 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HNO - Keratome, Ac-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.4370 |