FDA 510(k)

External Moisturizing Gel

Número K: K171855 · 2017-07-21

Data da decisão2017-07-21

Código do produtoNUC

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

External Moisturizing Gel is the device name listed in this FDA 510(k) record. The listed applicant is Combe Incorporated. It received FDA 510(k) clearance on 2017-07-21 under 510(k) number K171855. 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 External Moisturizing Gel?

External Moisturizing Gel is a medical device that received FDA 510(k) clearance on 2017-07-21. The listed applicant is Combe Incorporated. The 510(k) number is K171855.

When did External Moisturizing Gel receive FDA 510(k) clearance?

External Moisturizing Gel received FDA 510(k) clearance on 2017-07-21, under 510(k) number K171855.

Who is the listed applicant for External Moisturizing Gel?

The FDA 510(k) record lists Combe Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for External Moisturizing Gel?

The FDA product code for External Moisturizing Gel is NUC.

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