FDA 510(k)

3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System

K号: K180404 · 2018-03-16

决定日期2018-03-16

产品代码NJM

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决定实质等同

器械摘要

3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System is the device name listed in this FDA 510(k) record. The listed applicant is 3M Healthcare. It received FDA 510(k) clearance on 2018-03-16 under 510(k) number K180404. The device is classified under product code NJM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the 3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System?

3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System is a medical device that received FDA 510(k) clearance on 2018-03-16. The listed applicant is 3M Healthcare. The 510(k) number is K180404.

When did 3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System receive FDA 510(k) clearance?

3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System received FDA 510(k) clearance on 2018-03-16, under 510(k) number K180404.

Who is the listed applicant for 3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System?

The FDA 510(k) record lists 3M Healthcare as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System?

The FDA product code for 3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System is NJM.

列明3M Healthcare为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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