Submission Details
| 510(k) Number | K141674 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 23, 2014 |
| Decision Date | November 06, 2014 |
| Days to Decision | 136 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |