K890376 is an FDA 510(k) clearance for the VAGINAL SPECULUM. This device is classified as a Washer, Endometrial (Class II - Special Controls, product code HFD).
Submitted by Kinetic Medical Products (Erie, US). The FDA issued a Cleared decision on February 27, 1989, 35 days after receiving the submission on January 23, 1989.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1185.
| 510(k) Number | K890376 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 23, 1989 |
| Decision Date | February 27, 1989 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| Product Code | HFD — Washer, Endometrial |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1185 |