K964102 is an FDA 510(k) clearance for the TENET TIBIAL FRACTURE SUPPORT, a Chair, Surgical, Ac-powered (Class I — General Controls, product code GBB), submitted by Tenet Medical Engineering (Calgary Alberta, CA). The FDA issued a Cleared decision on December 5, 1996, 55 days after receiving the submission on October 11, 1996. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4960.
| 510(k) Number | K964102 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 11, 1996 |
| Decision Date | December 05, 1996 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | GBB — Chair, Surgical, Ac-powered |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4960 |