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FDA 510(k)

TN-Brush

K-Number: K170596 · 2017-09-11

ApplicantGenoss Co., Ltd.
Decision Date2017-09-11
Product CodeELB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TN-Brush is the device name listed in this FDA 510(k) record. The listed applicant is Genoss Co., Ltd.. It received FDA 510(k) clearance on 2017-09-11 under 510(k) number K170596. The device is classified under product code ELB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TN-Brush?

TN-Brush is a medical device that received FDA 510(k) clearance on 2017-09-11. The listed applicant is Genoss Co., Ltd.. The 510(k) number is K170596.

When did TN-Brush receive FDA 510(k) clearance?

TN-Brush received FDA 510(k) clearance on 2017-09-11, under 510(k) number K170596.

Who is the listed applicant for TN-Brush?

The FDA 510(k) record lists Genoss Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TN-Brush?

The FDA product code for TN-Brush is ELB.

Other records listing Genoss Co., Ltd. as applicant

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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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