Submission Details
| 510(k) Number | K133443 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 12, 2013 |
| Decision Date | July 10, 2014 |
| Days to Decision | 240 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |