Trippi-Wells Dual Purpose Universal Tong
FDA 510(k) K810193 · Ace Orthopedic Manufacturing Co.
510(k) numberK810193
Submission
- Device name
- Trippi-Wells Dual Purpose Universal Tong
- Applicant
- Ace Orthopedic Manufacturing Co.
Mchenry, IL, US - Received
- January 23, 1981
- Decision date
- March 20, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K791466 | Ace External Bone Clamp Part #S11JEC · Traditional | 08/16/1979SE |
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Questions and answers
When was Trippi-Wells Dual Purpose Universal Tong cleared by the FDA?
Trippi-Wells Dual Purpose Universal Tong (K810193) received a 510(k) decision of Substantially Equivalent on March 20, 1981, 56 days after the submission was received.
What is the product code of K810193?
The FDA product code is HAX – Tong, Skull For Traction, a Class II (moderate risk) device regulated under 21 CFR 882.5960.