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FDA 510(k)

BioNourish Lubricant

K-Number: K193448 · 2020-03-12

ApplicantGood Clean Love, Inc.
Decision Date2020-03-12
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

BioNourish Lubricant is the device name listed in this FDA 510(k) record. The listed applicant is Good Clean Love, Inc.. It received FDA 510(k) clearance on 2020-03-12 under 510(k) number K193448. 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 BioNourish Lubricant?

BioNourish Lubricant is a medical device that received FDA 510(k) clearance on 2020-03-12. The listed applicant is Good Clean Love, Inc.. The 510(k) number is K193448.

When did BioNourish Lubricant receive FDA 510(k) clearance?

BioNourish Lubricant received FDA 510(k) clearance on 2020-03-12, under 510(k) number K193448.

Who is the listed applicant for BioNourish Lubricant?

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

What is the FDA product code for BioNourish Lubricant?

The FDA product code for BioNourish Lubricant is NUC.

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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

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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