K082349 is an FDA 510(k) clearance for the JARIT HULKA UTERINE TENACULUM FORCEPS, a Tenaculum, Uterine (Class II — Special Controls, product code HDC), submitted by J. Jamner Surgical Instruments, Inc. (York, US). The FDA issued a Cleared decision on November 21, 2008, 98 days after receiving the submission on August 15, 2008. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K082349 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 15, 2008 |
| Decision Date | November 21, 2008 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HDC — Tenaculum, Uterine |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.4530 |