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FDA 510(k)

High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L)

K-Number: K233122 · 2024-04-30

ApplicantLitu Tech , Ltd.
Decision Date2024-04-30
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L) is a medical device manufactured by Litu Tech , Ltd.. It received FDA 510(k) clearance on 2024-04-30 under approval number K233122. 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 (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L)?

High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L) is a medical device that received FDA 510(k) clearance on 2024-04-30. It is manufactured by Litu Tech , Ltd.. The 510(k) number is K233122.

When was High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L) approved by the FDA?

High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L) received FDA 510(k) clearance on 2024-04-30, under approval number K233122.

What company makes High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L)?

High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L) is manufactured by Litu Tech , Ltd..

What is the FDA product code for High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L)?

The FDA product code for High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L) is EFB.

Related Devices (Code: 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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