Submission Details
| 510(k) Number | K944587 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 19, 1994 |
| Decision Date | October 30, 1995 |
| Days to Decision | 406 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |