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FDA 510(k)

Solevy Co. LLC Silicone Based Personal Lubricant

K-Number: K203644 · 2021-04-19

ApplicantSolevy Co., LLC
Decision Date2021-04-19
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Solevy Co. LLC Silicone Based Personal Lubricant is the device name listed in this FDA 510(k) record. The listed applicant is Solevy Co., LLC. It received FDA 510(k) clearance on 2021-04-19 under 510(k) number K203644. 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 Solevy Co. LLC Silicone Based Personal Lubricant?

Solevy Co. LLC Silicone Based Personal Lubricant is a medical device that received FDA 510(k) clearance on 2021-04-19. The listed applicant is Solevy Co., LLC. The 510(k) number is K203644.

When did Solevy Co. LLC Silicone Based Personal Lubricant receive FDA 510(k) clearance?

Solevy Co. LLC Silicone Based Personal Lubricant received FDA 510(k) clearance on 2021-04-19, under 510(k) number K203644.

Who is the listed applicant for Solevy Co. LLC Silicone Based Personal Lubricant?

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

What is the FDA product code for Solevy Co. LLC Silicone Based Personal Lubricant?

The FDA product code for Solevy Co. LLC Silicone Based Personal Lubricant is NUC.

Other records listing Solevy Co., 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.

K203654Solevy Co. LLC Water-Based Personal 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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