FDA 510(k)

Mini and Micro Fragments Reconstruction System – GMReis

Número K: K182718 · 2019-12-23

RequerenteGm Dos Reis Industria E Comerico Ltda.

Data da decisão2019-12-23

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Mini and Micro Fragments Reconstruction System – GMReis is the device name listed in this FDA 510(k) record. The listed applicant is Gm Dos Reis Industria E Comerico Ltda.. It received FDA 510(k) clearance on 2019-12-23 under 510(k) number K182718. 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 Mini and Micro Fragments Reconstruction System – GMReis?

Mini and Micro Fragments Reconstruction System – GMReis is a medical device that received FDA 510(k) clearance on 2019-12-23. The listed applicant is Gm Dos Reis Industria E Comerico Ltda.. The 510(k) number is K182718.

When did Mini and Micro Fragments Reconstruction System – GMReis receive FDA 510(k) clearance?

Mini and Micro Fragments Reconstruction System – GMReis received FDA 510(k) clearance on 2019-12-23, under 510(k) number K182718.

Who is the listed applicant for Mini and Micro Fragments Reconstruction System – GMReis?

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

What is the FDA product code for Mini and Micro Fragments Reconstruction System – GMReis?

The FDA product code for Mini and Micro Fragments Reconstruction System – GMReis is HRS.

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Fonte oficial

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