Submission Details
| 510(k) Number | K153317 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 18, 2015 |
| Decision Date | November 30, 2016 |
| Days to Decision | 378 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |