K992736 is an FDA 510(k) clearance for the WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM, a Speculum, Vaginal, Nonmetal (Class II — Special Controls, product code HIB), submitted by Wallach Surgical Devices, Inc. (Orange, US). The FDA issued a Cleared decision on September 29, 1999, 47 days after receiving the submission on August 13, 1999. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K992736 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 13, 1999 |
| Decision Date | September 29, 1999 |
| Days to Decision | 47 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HIB — Speculum, Vaginal, Nonmetal |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.4530 |