FDA 510(k)

Luce Ceramic Bracket

K-Number: K201038 · 2020-10-09

Decision Date2020-10-09

Product CodeNJM

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Luce Ceramic Bracket is a medical device manufactured by Luce Castle Co., Ltd.. It received FDA 510(k) clearance on 2020-10-09 under approval number K201038. The device is classified under product code NJM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Luce Ceramic Bracket?

Luce Ceramic Bracket is a medical device that received FDA 510(k) clearance on 2020-10-09. It is manufactured by Luce Castle Co., Ltd.. The 510(k) number is K201038.

When was Luce Ceramic Bracket approved by the FDA?

Luce Ceramic Bracket received FDA 510(k) clearance on 2020-10-09, under approval number K201038.

What company makes Luce Ceramic Bracket?

Luce Ceramic Bracket is manufactured by Luce Castle Co., Ltd..

What is the FDA product code for Luce Ceramic Bracket?

The FDA product code for Luce Ceramic Bracket is NJM.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.