Submission Details
| 510(k) Number | K781715 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 05, 1978 |
| Decision Date | December 04, 1978 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |