Submission Details
| 510(k) Number | K992685 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 10, 1999 |
| Decision Date | October 06, 1999 |
| Days to Decision | 57 days |
| Submission Type | Special |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |