Submission Details
| 510(k) Number | K981032 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 19, 1998 |
| Decision Date | September 02, 1998 |
| Days to Decision | 167 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |