Tenet Tibial Fracture Support
FDA 510(k) K964102 · Tenet Medical Engineering
510(k) numberK964102
Submission
- Device name
- Tenet Tibial Fracture Support
- Applicant
- Tenet Medical Engineering
Calgary Alberta, CA - Received
- October 11, 1996
- Decision date
- December 5, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GBB – Chair, Surgical, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4960
- Specialty
- General, Plastic Surgery
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| K822264 | Nagashima SN Operator's ChairGBB · Traditional | Kelleher Corp. | 10/13/1982SE |
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| K822013 | Nagashima SN Automatic Treatment ChairGBB · Traditional | Kelleher Corp. | 07/28/1982SE |
| K820636 | Storz #6500 Power Examination ChairGBB · Traditional | Storz Instrument Co. | 03/26/1982SE |
More from Storz Instrument Co.
Questions and answers
When was Tenet Tibial Fracture Support cleared by the FDA?
Tenet Tibial Fracture Support (K964102) received a 510(k) decision of Substantially Equivalent on December 5, 1996, 55 days after the submission was received.
What is the product code of K964102?
The FDA product code is GBB – Chair, Surgical, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 878.4960.