FDA 510(k)

Replens Long-Lasting Vaginal Moisturizer

Número K: K203818 · 2021-06-11

Data da decisão2021-06-11

Código do produtoNUC

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Replens Long-Lasting Vaginal Moisturizer is the device name listed in this FDA 510(k) record. The listed applicant is Church & Dwight Co., Inc.. It received FDA 510(k) clearance on 2021-06-11 under 510(k) number K203818. 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 Replens Long-Lasting Vaginal Moisturizer?

Replens Long-Lasting Vaginal Moisturizer is a medical device that received FDA 510(k) clearance on 2021-06-11. The listed applicant is Church & Dwight Co., Inc.. The 510(k) number is K203818.

When did Replens Long-Lasting Vaginal Moisturizer receive FDA 510(k) clearance?

Replens Long-Lasting Vaginal Moisturizer received FDA 510(k) clearance on 2021-06-11, under 510(k) number K203818.

Who is the listed applicant for Replens Long-Lasting Vaginal Moisturizer?

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

What is the FDA product code for Replens Long-Lasting Vaginal Moisturizer?

The FDA product code for Replens Long-Lasting Vaginal Moisturizer is NUC.

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Fonte oficial

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