Submission Details
| 510(k) Number | K152923 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 05, 2015 |
| Decision Date | November 05, 2015 |
| Days to Decision | 31 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |