FDA 510(k)

LubriZenzs

Número K: K242712 · 2025-06-04

Data da decisão2025-06-04

Código do produtoNUC

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

LubriZenzs is the device name listed in this FDA 510(k) record. The listed applicant is Sk Zen, LLC. It received FDA 510(k) clearance on 2025-06-04 under 510(k) number K242712. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the LubriZenzs?

LubriZenzs is a medical device that received FDA 510(k) clearance on 2025-06-04. The listed applicant is Sk Zen, LLC. The 510(k) number is K242712.

When did LubriZenzs receive FDA 510(k) clearance?

LubriZenzs received FDA 510(k) clearance on 2025-06-04, under 510(k) number K242712.

Who is the listed applicant for LubriZenzs?

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

What is the FDA product code for LubriZenzs?

The FDA product code for LubriZenzs is NUC.

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Fonte oficial

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