Submission Details
| 510(k) Number | K810017 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Product Development Protocol (SESP) |
| Date Received | January 05, 1981 |
| Decision Date | January 05, 1981 |
| Days to Decision | — |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |