Submission Details
| 510(k) Number | K843499 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 06, 1984 |
| Decision Date | October 31, 1984 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |