K072942 is an FDA 510(k) clearance for the MEDLINE DISPOSABLE VAGINAL SPECULUM. This device is classified as a Speculum, Vaginal, Nonmetal (Class II - Special Controls, product code HIB).
Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on February 8, 2008, 114 days after receiving the submission on October 17, 2007.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K072942 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 17, 2007 |
| Decision Date | February 08, 2008 |
| Days to Decision | 114 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | HIB — Speculum, Vaginal, Nonmetal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4530 |