K974286 is an FDA 510(k) clearance for the CIRCUMCISION TRAY, CAT. NO. 70340, a Clamp, Circumcision (Class II — Special Controls, product code HFX), submitted by Trinity Laboratories, Inc. (Salisbury, US). The FDA issued a Cleared decision on December 12, 1997, 28 days after receiving the submission on November 14, 1997. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K974286 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 14, 1997 |
| Decision Date | December 12, 1997 |
| Days to Decision | 28 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 |