Submission Details
| 510(k) Number | K120930 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 27, 2012 |
| Decision Date | October 26, 2012 |
| Days to Decision | 213 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |