Submission Details
| 510(k) Number | K854968 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 11, 1985 |
| Decision Date | April 04, 1986 |
| Days to Decision | 114 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | - |