Submission Details
| 510(k) Number | K171842 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 20, 2017 |
| Decision Date | November 03, 2017 |
| Days to Decision | 136 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |