Submission Details
| 510(k) Number | K060456 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 22, 2006 |
| Decision Date | June 19, 2006 |
| Days to Decision | 117 days |
| Submission Type | Abbreviated |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |