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FDA 510(k)

High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors

K-Number: K220179 · 2023-09-22

ApplicantFoshan Coxo Medical Instrument Co., Ltd.
Decision Date2023-09-22
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors is a medical device manufactured by Foshan Coxo Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2023-09-22 under approval number K220179. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors?

High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors is a medical device that received FDA 510(k) clearance on 2023-09-22. It is manufactured by Foshan Coxo Medical Instrument Co., Ltd.. The 510(k) number is K220179.

When was High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors approved by the FDA?

High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors received FDA 510(k) clearance on 2023-09-22, under approval number K220179.

What company makes High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors?

High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors is manufactured by Foshan Coxo Medical Instrument Co., Ltd..

What is the FDA product code for High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors?

The FDA product code for High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors is EFB.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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