K950968 is an FDA 510(k) clearance for the TETRAFILCON A HYDROPHILIC CONTACT LENSES. This device is classified as a Lenses, Soft Contact, Daily Wear (Class II - Special Controls, product code LPL).
Submitted by CooperVision, Inc. (Scottsville,, US). The FDA issued a Cleared decision on July 25, 1995, 146 days after receiving the submission on March 1, 1995.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5925.
| 510(k) Number | K950968 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 1995 |
| Decision Date | July 25, 1995 |
| Days to Decision | 146 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | LPL — Lenses, Soft Contact, Daily Wear |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.5925 |