Submission Details
| 510(k) Number | K152721 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 21, 2015 |
| Decision Date | December 08, 2015 |
| Days to Decision | 78 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |