Submission Details
| 510(k) Number | K984187 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 23, 1998 |
| Decision Date | February 18, 1999 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |