The following data is part of a premarket notification filed by Tenet Medical Engineering with the FDA for Tenet Tibial Fracture Support.
| Device ID | K964102 |
| 510k Number | K964102 |
| Device Name: | TENET TIBIAL FRACTURE SUPPORT |
| Classification | Chair, Surgical, Ac-powered |
| Applicant | TENET MEDICAL ENGINEERING 2ND. FLOOR 2004 - 10 AVE. S.W. Calgary Alberta, CA T3c Oj8 |
| Contact | Ken Moore |
| Correspondent | Ken Moore TENET MEDICAL ENGINEERING 2ND. FLOOR 2004 - 10 AVE. S.W. Calgary Alberta, CA T3c Oj8 |
| Product Code | GBB |
| CFR Regulation Number | 878.4960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-11 |
| Decision Date | 1996-12-05 |