Submission Details
| 510(k) Number | K113836 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 28, 2011 |
| Decision Date | September 24, 2012 |
| Days to Decision | 271 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |