FDA 510(k)

JO Premium Jelly Original Personal Lubricant

Número K: K191214 · 2019-08-01

Data da decisão2019-08-01

Código do produtoNUC

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

JO Premium Jelly 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 2019-08-01 under 510(k) number K191214. 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 Premium Jelly Original Personal Lubricant?

JO Premium Jelly Original Personal Lubricant is a medical device that received FDA 510(k) clearance on 2019-08-01. The listed applicant is United Consortium. The 510(k) number is K191214.

When did JO Premium Jelly Original Personal Lubricant receive FDA 510(k) clearance?

JO Premium Jelly Original Personal Lubricant received FDA 510(k) clearance on 2019-08-01, under 510(k) number K191214.

Who is the listed applicant for JO Premium Jelly 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 Premium Jelly Original Personal Lubricant?

The FDA product code for JO Premium Jelly Original Personal Lubricant is NUC.

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Outros registros que listam United Consortium como candidato(a)

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Fonte oficial

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