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FDA 510(k)

Replens Long-Lasting Vaginal Moisturizer

K-Number: K203818 · 2021-06-11

ApplicantChurch & Dwight Co., Inc.
Decision Date2021-06-11
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Replens Long-Lasting Vaginal Moisturizer is a medical device manufactured by Church & Dwight Co., Inc.. It received FDA 510(k) clearance on 2021-06-11 under approval number K203818. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Church & Dwight Co., Inc.. The 510(k) number is K203818.

When was Replens Long-Lasting Vaginal Moisturizer approved by the FDA?

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

What company makes Replens Long-Lasting Vaginal Moisturizer?

Replens Long-Lasting Vaginal Moisturizer is manufactured by Church & Dwight Co., Inc..

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

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

Related Clinical Trials

NCT07038070 Via, a Hyaluronic Acid (HLA) Based Vaginal Moisturizer Study WITHDRAWN

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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