Submission Details
| 510(k) Number | K945020 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 12, 1994 |
| Decision Date | December 23, 1994 |
| Days to Decision | 72 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |