FDA 510(k)

Quick - Radius Disposable Set

Número K: K231684 · 2024-01-12

RequerenteGM Dos Reis Industria e Comercio Ltda.

Data da decisão2024-01-12

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Quick - Radius Disposable Set is the device name listed in this FDA 510(k) record. The listed applicant is GM Dos Reis Industria e Comercio Ltda.. It received FDA 510(k) clearance on 2024-01-12 under 510(k) number K231684. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Quick - Radius Disposable Set?

Quick - Radius Disposable Set is a medical device that received FDA 510(k) clearance on 2024-01-12. The listed applicant is GM Dos Reis Industria e Comercio Ltda.. The 510(k) number is K231684.

When did Quick - Radius Disposable Set receive FDA 510(k) clearance?

Quick - Radius Disposable Set received FDA 510(k) clearance on 2024-01-12, under 510(k) number K231684.

Who is the listed applicant for Quick - Radius Disposable Set?

The FDA 510(k) record lists GM Dos Reis Industria e Comercio Ltda. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Quick - Radius Disposable Set?

The FDA product code for Quick - Radius Disposable Set is HRS.

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Fonte oficial

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