Submission Details
| 510(k) Number | K926408 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 1992 |
| Decision Date | February 02, 1994 |
| Days to Decision | 408 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |