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FDA 510(k)

High-speed air turbine handpiece / Low-speed air turbine handpiece

K-Number: K181691 · 2020-05-26

ApplicantFoshan Wenjian Medical Instrument Co., Ltd.
Decision Date2020-05-26
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

High-speed air turbine handpiece / Low-speed air turbine handpiece is a medical device manufactured by Foshan Wenjian Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2020-05-26 under approval number K181691. 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 handpiece / Low-speed air turbine handpiece?

High-speed air turbine handpiece / Low-speed air turbine handpiece is a medical device that received FDA 510(k) clearance on 2020-05-26. It is manufactured by Foshan Wenjian Medical Instrument Co., Ltd.. The 510(k) number is K181691.

When was High-speed air turbine handpiece / Low-speed air turbine handpiece approved by the FDA?

High-speed air turbine handpiece / Low-speed air turbine handpiece received FDA 510(k) clearance on 2020-05-26, under approval number K181691.

What company makes High-speed air turbine handpiece / Low-speed air turbine handpiece?

High-speed air turbine handpiece / Low-speed air turbine handpiece is manufactured by Foshan Wenjian Medical Instrument Co., Ltd..

What is the FDA product code for High-speed air turbine handpiece / Low-speed air turbine handpiece?

The FDA product code for High-speed air turbine handpiece / Low-speed air turbine handpiece 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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