Submission Details
| 510(k) Number | K842909 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 25, 1984 |
| Decision Date | October 05, 1984 |
| Days to Decision | 72 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |