FDA 510(k)

Gel de Sexo

Número K: K181078 · 2018-09-10

Data da decisão2018-09-10

Código do produtoNUC

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

The Sex Gel is the device name listed in this FDA 510(k) record. The listed applicant is Necessaire, Inc.. It received FDA 510(k) clearance on 2018-09-10 under 510(k) number K181078. 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 The Sex Gel?

The Sex Gel is a medical device that received FDA 510(k) clearance on 2018-09-10. The listed applicant is Necessaire, Inc.. The 510(k) number is K181078.

When did The Sex Gel receive FDA 510(k) clearance?

The Sex Gel received FDA 510(k) clearance on 2018-09-10, under 510(k) number K181078.

Who is the listed applicant for The Sex Gel?

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

What is the FDA product code for The Sex Gel?

The FDA product code for The Sex Gel is NUC.

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Fonte oficial

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