Submission Details
| 510(k) Number | K993870 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 15, 1999 |
| Decision Date | January 18, 2000 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |