Submission Details
| 510(k) Number | K001737 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 07, 2000 |
| Decision Date | June 19, 2000 |
| Days to Decision | 12 days |
| Submission Type | Special |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |