FDA 510(k)

JO for Him H2O Gel Original Personal Lubricant

Número K: K192203 · 2020-02-10

Data da decisão2020-02-10

Código do produtoNUC

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

JO for Him H2O Gel Original Personal Lubricant is the device name listed in this FDA 510(k) record. The listed applicant is United Consortium. It received FDA 510(k) clearance on 2020-02-10 under 510(k) number K192203. 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 JO for Him H2O Gel Original Personal Lubricant?

JO for Him H2O Gel Original Personal Lubricant is a medical device that received FDA 510(k) clearance on 2020-02-10. The listed applicant is United Consortium. The 510(k) number is K192203.

When did JO for Him H2O Gel Original Personal Lubricant receive FDA 510(k) clearance?

JO for Him H2O Gel Original Personal Lubricant received FDA 510(k) clearance on 2020-02-10, under 510(k) number K192203.

Who is the listed applicant for JO for Him H2O Gel Original Personal Lubricant?

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

What is the FDA product code for JO for Him H2O Gel Original Personal Lubricant?

The FDA product code for JO for Him H2O Gel Original Personal Lubricant is NUC.

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Fonte oficial

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