Submission Details
| 510(k) Number | K140117 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 16, 2014 |
| Decision Date | February 11, 2014 |
| Days to Decision | 26 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |