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FDA 510(k)

Sage 2-in-1 Personal Lubricant and Moisturizer

K-Number: K190150 · 2019-07-16

ApplicantFairhaven Health, LLC
Decision Date2019-07-16
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Sage 2-in-1 Personal Lubricant and Moisturizer is the device name listed in this FDA 510(k) record. The listed applicant is Fairhaven Health, LLC. It received FDA 510(k) clearance on 2019-07-16 under 510(k) 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. The listed applicant is Fairhaven Health, LLC. The 510(k) number is K190150.

When did Sage 2-in-1 Personal Lubricant and Moisturizer receive FDA 510(k) clearance?

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

Who is the listed applicant for Sage 2-in-1 Personal Lubricant and Moisturizer?

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

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 records listing Fairhaven Health, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K162319BabyDance Fertility Lubricant

Related Devices (Code: NUC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261905BUM OilBumlicious, LLC (DBA “Bumlicious”)K261177PINKSLIP Water-Based Personal Lubricant and MoisturizerPINKSLIP, LLCK261909Plum Vagiceuticals™ Vaginal Moisturizing SuppositoriesPCCA, Inc.K254011Flow Water-Based Personal LubricantLBDO Group, Inc.K261292PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)PR Personal Care LaboratoriesK252914Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)Hathor Professional Skincare , Ltd.

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.

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