FDA 510(k)

OssGuide

Número K: K200623 · 2020-10-02

Data da decisão2020-10-02

Código do produtoNPL

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

OssGuide is the device name listed in this FDA 510(k) record. The listed applicant is Sk Bioland Co., Ltd.. It received FDA 510(k) clearance on 2020-10-02 under 510(k) number K200623. The device is classified under product code NPL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the OssGuide?

OssGuide is a medical device that received FDA 510(k) clearance on 2020-10-02. The listed applicant is Sk Bioland Co., Ltd.. The 510(k) number is K200623.

When did OssGuide receive FDA 510(k) clearance?

OssGuide received FDA 510(k) clearance on 2020-10-02, under 510(k) number K200623.

Who is the listed applicant for OssGuide?

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

What is the FDA product code for OssGuide?

The FDA product code for OssGuide is NPL.

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