K984306 is an FDA 510(k) clearance for the `THE INSEMINATOR' (PROPOSED), a Cannula, Intrauterine Insemination (Class II — Special Controls, product code MFD), submitted by Wallach Surgical Devices, Inc. (Orange, US). The FDA issued a Cleared decision on March 1, 1999, 89 days after receiving the submission on December 2, 1998. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5250.
| 510(k) Number | K984306 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 02, 1998 |
| Decision Date | March 01, 1999 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MFD — Cannula, Intrauterine Insemination |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.5250 |