K962934 is an FDA 510(k) clearance for the AIRPERM(SIFLUFOCON A) RIGID GAS PERMEABLE MULTIFOCAL CONTACT LENSES FOR DAILY WEAR. This device is classified as a Lens, Contact (other Material) - Daily (Class II - Special Controls, product code HQD).
Submitted by Airperm, Inc. (Sherman Oaks, US). The FDA issued a Cleared decision on August 27, 1996, 29 days after receiving the submission on July 29, 1996.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5916.
| 510(k) Number | K962934 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 29, 1996 |
| Decision Date | August 27, 1996 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HQD — Lens, Contact (other Material) - Daily |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.5916 |