K000444 is an FDA 510(k) clearance for the MITYVIEW 4-WAY LATERAL EXPANDER SPECULUM. This device is classified as a Speculum, Vaginal, Nonmetal (Class II — Special Controls, product code HIB).
Submitted by Prism Enterprises, Inc. (San Antonio, US). The FDA issued a Cleared decision on April 21, 2000, 71 days after receiving the submission on February 10, 2000.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K000444 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 10, 2000 |
| Decision Date | April 21, 2000 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HIB — Speculum, Vaginal, Nonmetal |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.4530 |