FDA 510(k)

3M Clarity Ultra Parafusos Auto-Ligantes e Sistema de Dispositivo Coberto com Adesivo

Número K: K180404 · 2018-03-16

Data da decisão2018-03-16

Código do produtoNJM

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Fonte oficial

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