K895411 is an FDA 510(k) clearance for the OPTIKEM PMMA CONTACT LENS. This device is classified as a Lens, Contact (polymethylmethacrylate).
Submitted by Optikem Polymers, Inc. (Englewood, US). The FDA issued a Cleared decision on February 27, 1990, 174 days after receiving the submission on September 6, 1989.
This device falls under the Ophthalmic FDA review panel.
| 510(k) Number | K895411 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 06, 1989 |
| Decision Date | February 27, 1990 |
| Days to Decision | 174 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HPX — Lens, Contact (polymethylmethacrylate) |
| Device Class | — |