K830725 is an FDA 510(k) clearance for the GENT-L-SPEC DISPOS. VAGINAL SPECULUM. This device is classified as a Speculum, Vaginal, Nonmetal (Class II - Special Controls, product code HIB).
Submitted by Geneva Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 27, 1983, 50 days after receiving the submission on March 8, 1983.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K830725 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 08, 1983 |
| Decision Date | April 27, 1983 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| Product Code | HIB — Speculum, Vaginal, Nonmetal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4530 |