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FDA 510(k)

LUBRIGEL PERSONAL LUBRICANT

K-Number: K001077 · 2000-08-02

ApplicantSheffield Laboratories, Div. of Faria Limited, LLC
Decision Date2000-08-02
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LUBRIGEL PERSONAL LUBRICANT is the device name listed in this FDA 510(k) record. The listed applicant is Sheffield Laboratories, Div. of Faria Limited, LLC. It received FDA 510(k) clearance on 2000-08-02 under 510(k) number K001077. 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 LUBRIGEL PERSONAL LUBRICANT?

LUBRIGEL PERSONAL LUBRICANT is a medical device that received FDA 510(k) clearance on 2000-08-02. The listed applicant is Sheffield Laboratories, Div. of Faria Limited, LLC. The 510(k) number is K001077.

When did LUBRIGEL PERSONAL LUBRICANT receive FDA 510(k) clearance?

LUBRIGEL PERSONAL LUBRICANT received FDA 510(k) clearance on 2000-08-02, under 510(k) number K001077.

Who is the listed applicant for LUBRIGEL PERSONAL LUBRICANT?

The FDA 510(k) record lists Sheffield Laboratories, Div. of Faria Limited, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LUBRIGEL PERSONAL LUBRICANT?

The FDA product code for LUBRIGEL PERSONAL LUBRICANT is NUC.

Related Clinical Trials

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.

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Other records listing Sheffield Laboratories, Div. of Faria Limited, 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.

K052162SHEFFIELD BRAND WARMING LUBRIGEL 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.

K260117EverslideSpecial Situations, LLCK253989HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU STEAMY water based lubricant (WL-ST)Maxigen Biotech, Inc.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.

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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