FDA 510(k)

JO Gelato Flavored Personal Lubricants

Número K: K172447 · 2017-10-31

Data da decisão2017-10-31

Código do produtoNUC

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

JO Gelato 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 2017-10-31 under 510(k) number K172447. 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 Gelato Flavored Personal Lubricants?

JO Gelato Flavored Personal Lubricants is a medical device that received FDA 510(k) clearance on 2017-10-31. The listed applicant is United Consortium. The 510(k) number is K172447.

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

JO Gelato Flavored Personal Lubricants received FDA 510(k) clearance on 2017-10-31, under 510(k) number K172447.

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

The FDA product code for JO Gelato 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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