K902019 is an FDA 510(k) clearance for the MODIFIED METAL SPECULUM & SPECIAL BULLET FORCEPS. This device is classified as a Speculum, Vaginal, Metal (Class I — General Controls, product code HDF).
Submitted by Gynescope Corp. (Willoughby, US). The FDA issued a Cleared decision on June 7, 1990, 35 days after receiving the submission on May 3, 1990.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4520.
| 510(k) Number | K902019 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 03, 1990 |
| Decision Date | June 07, 1990 |
| Days to Decision | 35 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 |