Submission Details
| 510(k) Number | K820818 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 24, 1982 |
| Decision Date | April 09, 1982 |
| Days to Decision | 16 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | - |