Submission Details
| 510(k) Number | K143069 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 27, 2014 |
| Decision Date | December 22, 2014 |
| Days to Decision | 56 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |