Submission Details
| 510(k) Number | K862542 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 03, 1986 |
| Decision Date | August 04, 1986 |
| Days to Decision | 32 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |