Submission Details
| 510(k) Number | K862039 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Direct De Novo (SESD) |
| Date Received | May 28, 1986 |
| Decision Date | July 03, 1986 |
| Days to Decision | 36 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |