Submission Details
| 510(k) Number | K842781 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Direct De Novo (SESD) |
| Date Received | July 16, 1984 |
| Decision Date | August 01, 1985 |
| Days to Decision | 381 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |