Submission Details
| 510(k) Number | K915150 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 14, 1991 |
| Decision Date | January 09, 1992 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |