FDA 510(k)

Sage 2-in-1 Personal Lubricant and Moisturizer

K-Number: K190150 · 2019-07-16

Decision Date2019-07-16

Product CodeNUC

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

Sage 2-in-1 Personal Lubricant and Moisturizer is a medical device manufactured by Fairhaven Health, LLC. It received FDA 510(k) clearance on 2019-07-16 under approval number K190150. 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 Sage 2-in-1 Personal Lubricant and Moisturizer?

Sage 2-in-1 Personal Lubricant and Moisturizer is a medical device that received FDA 510(k) clearance on 2019-07-16. It is manufactured by Fairhaven Health, LLC. The 510(k) number is K190150.

When was Sage 2-in-1 Personal Lubricant and Moisturizer approved by the FDA?

Sage 2-in-1 Personal Lubricant and Moisturizer received FDA 510(k) clearance on 2019-07-16, under approval number K190150.

What company makes Sage 2-in-1 Personal Lubricant and Moisturizer?

Sage 2-in-1 Personal Lubricant and Moisturizer is manufactured by Fairhaven Health, LLC.

What is the FDA product code for Sage 2-in-1 Personal Lubricant and Moisturizer?

The FDA product code for Sage 2-in-1 Personal Lubricant and Moisturizer is NUC.

Other Devices by Fairhaven Health, LLC

K162319BabyDance Fertility Lubricant

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Official Source

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