K943784 is an FDA 510(k) clearance for the MELAFOCON A/RIGID GAS PERM CONTACT LEN FOR DAILY WEAR. This device is classified as a Lens, Contact (other Material) - Daily (Class II - Special Controls, product code HQD).
Submitted by Menicon Co, Ltd. (Washington, US). The FDA issued a Cleared decision on October 20, 1994, 86 days after receiving the submission on July 26, 1994.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5916.
| 510(k) Number | K943784 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 26, 1994 |
| Decision Date | October 20, 1994 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | HQD - Lens, Contact (other Material) - Daily |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.5916 |