Submission Details
| 510(k) Number | K072378 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 24, 2007 |
| Decision Date | November 09, 2007 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |