Submission Details
| 510(k) Number | K172595 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 29, 2017 |
| Decision Date | September 28, 2017 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |