Submission Details
| 510(k) Number | K924020 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 11, 1992 |
| Decision Date | December 28, 1992 |
| Days to Decision | 139 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |