FDA 510(k)

JO H2O Flavored Personal Lubricants

Número K: K180219 · 2018-04-20

Data da decisão2018-04-20

Código do produtoNUC

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

JO H2O Flavored Personal Lubricants is the device name listed in this FDA 510(k) record. The listed applicant is United Consortium. It received FDA 510(k) clearance on 2018-04-20 under 510(k) number K180219. 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 H2O Flavored Personal Lubricants?

JO H2O Flavored Personal Lubricants is a medical device that received FDA 510(k) clearance on 2018-04-20. The listed applicant is United Consortium. The 510(k) number is K180219.

When did JO H2O Flavored Personal Lubricants receive FDA 510(k) clearance?

JO H2O Flavored Personal Lubricants received FDA 510(k) clearance on 2018-04-20, under 510(k) number K180219.

Who is the listed applicant for JO H2O Flavored Personal Lubricants?

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 H2O Flavored Personal Lubricants?

The FDA product code for JO H2O Flavored Personal Lubricants 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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