K955366 is an FDA 510(k) clearance for the TRANS-AIRE RIGID GAS PERMABLE CONTACT LENS. This device is classified as a Lens, Contact (other Material) - Daily (Class II - Special Controls, product code HQD).
Submitted by Rand Scientific Corp. (Sacramento, US). The FDA issued a Cleared decision on March 28, 1996, 127 days after receiving the submission on November 22, 1995.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5916.
| 510(k) Number | K955366 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 22, 1995 |
| Decision Date | March 28, 1996 |
| Days to Decision | 127 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 |