Submission Details
| 510(k) Number | K863662 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 18, 1986 |
| Decision Date | October 20, 1986 |
| Days to Decision | 32 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |