K926429 is an FDA 510(k) clearance for the VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT, a Speculum, Vaginal, Metal (Class I — General Controls, product code HDF), submitted by Thomasville Medical Assoc. (Alpharetta, US). The FDA issued a Cleared decision on February 28, 1994, 432 days after receiving the submission on December 23, 1992. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4520.
| 510(k) Number | K926429 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 23, 1992 |
| Decision Date | February 28, 1994 |
| Days to Decision | 432 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | HDF — Speculum, Vaginal, Metal |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 884.4520 |