K955777 is an FDA 510(k) clearance for the PMMA CLASIC. This device is classified as a Lens, Contact (polymethylmethacrylate).
Submitted by Rand Scientific Corp. (Sacramento, US). The FDA issued a Cleared decision on May 16, 1996, 148 days after receiving the submission on December 20, 1995.
This device falls under the Ophthalmic FDA review panel.
| 510(k) Number | K955777 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 1995 |
| Decision Date | May 16, 1996 |
| Days to Decision | 148 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HPX — Lens, Contact (polymethylmethacrylate) |
| Device Class | — |