K862478 is an FDA 510(k) clearance for the HAYES VAGINAL SHIELD. This device is classified as a Speculum, Vaginal, Metal (Class I - General Controls, product code HDF).
Submitted by Franklin Medical USA, Inc. (Southfield, US). The FDA issued a Cleared decision on November 24, 1986, 147 days after receiving the submission on June 30, 1986.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4520.
| 510(k) Number | K862478 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 30, 1986 |
| Decision Date | November 24, 1986 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| Product Code | HDF — Speculum, Vaginal, Metal |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 884.4520 |