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FDA 510(k)

Bright High Flow

K-Number: K200155 · 2020-11-30

ApplicantGenoss Co., Ltd.
Decision Date2020-11-30
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Bright High Flow 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 2020-11-30 under 510(k) number K200155. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bright High Flow?

Bright High Flow is a medical device that received FDA 510(k) clearance on 2020-11-30. The listed applicant is Genoss Co., Ltd.. The 510(k) number is K200155.

When did Bright High Flow receive FDA 510(k) clearance?

Bright High Flow received FDA 510(k) clearance on 2020-11-30, under 510(k) number K200155.

Who is the listed applicant for Bright High Flow?

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 Bright High Flow?

The FDA product code for Bright High Flow is EBF.

Other records listing Genoss Co., Ltd. as applicant

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Related Devices (Code: EBF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K261246SRGC-06GC America, Inc.K261093DIAFILDiaDent Group InternationalK261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)DiaDent Group InternationalK260805Dual CoreVericom Co., Ltd.

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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