Bright Bond Universal
K-Number: K200153 · 2020-10-28
ApplicantGenoss Co., Ltd.
Decision Date2020-10-28
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Bright Bond Universal is a medical device manufactured by Genoss Co., Ltd.. It received FDA 510(k) clearance on 2020-10-28 under approval number K200153. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Bright Bond Universal?
Bright Bond Universal is a medical device that received FDA 510(k) clearance on 2020-10-28. It is manufactured by Genoss Co., Ltd.. The 510(k) number is K200153.
When was Bright Bond Universal approved by the FDA?
Bright Bond Universal received FDA 510(k) clearance on 2020-10-28, under approval number K200153.
What company makes Bright Bond Universal?
Bright Bond Universal is manufactured by Genoss Co., Ltd..
What is the FDA product code for Bright Bond Universal?
The FDA product code for Bright Bond Universal is KLE.
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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.