FDA 510(k)

Flap Fixator, Burr Hole Cover

Número K: K192310 · 2020-06-03

Data da decisão2020-06-03

Código do produtoGXR

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Flap Fixator, Burr Hole Cover is the device name listed in this FDA 510(k) record. The listed applicant is Ossaware Biotech Co., Ltd.. It received FDA 510(k) clearance on 2020-06-03 under 510(k) number K192310. The device is classified under product code GXR. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Flap Fixator, Burr Hole Cover?

Flap Fixator, Burr Hole Cover is a medical device that received FDA 510(k) clearance on 2020-06-03. The listed applicant is Ossaware Biotech Co., Ltd.. The 510(k) number is K192310.

When did Flap Fixator, Burr Hole Cover receive FDA 510(k) clearance?

Flap Fixator, Burr Hole Cover received FDA 510(k) clearance on 2020-06-03, under 510(k) number K192310.

Who is the listed applicant for Flap Fixator, Burr Hole Cover?

The FDA 510(k) record lists Ossaware Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Flap Fixator, Burr Hole Cover?

The FDA product code for Flap Fixator, Burr Hole Cover is GXR.

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Fonte oficial

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