K935491 is an FDA 510(k) clearance for the CENTURION MOGEN CLAMP/CIRCUMCISION (STER/NON STER), a Clamp, Circumcision (Class II — Special Controls, product code HFX), submitted by Tri-State Hospital Supply Corp. (Howell, US). The FDA issued a Cleared decision on February 17, 1994, 94 days after receiving the submission on November 15, 1993. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K935491 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 15, 1993 |
| Decision Date | February 17, 1994 |
| Days to Decision | 94 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | HFX — Clamp, Circumcision |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.4530 |