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FDA 510(k)

PERSONAL LUBRICATING GEL

K-Number: K041129 · 2004-09-24

ApplicantQualis, Inc.
Decision Date2004-09-24
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

PERSONAL LUBRICATING GEL is the device name listed in this FDA 510(k) record. The listed applicant is Qualis, Inc.. It received FDA 510(k) clearance on 2004-09-24 under 510(k) number K041129. 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 PERSONAL LUBRICATING GEL?

PERSONAL LUBRICATING GEL is a medical device that received FDA 510(k) clearance on 2004-09-24. The listed applicant is Qualis, Inc.. The 510(k) number is K041129.

When did PERSONAL LUBRICATING GEL receive FDA 510(k) clearance?

PERSONAL LUBRICATING GEL received FDA 510(k) clearance on 2004-09-24, under 510(k) number K041129.

Who is the listed applicant for PERSONAL LUBRICATING GEL?

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

What is the FDA product code for PERSONAL LUBRICATING GEL?

The FDA product code for PERSONAL LUBRICATING GEL is NUC.

Related Clinical Trials

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Other records listing Qualis, Inc. 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.

K050212PERSONAL WARMING JELLYK050211PERSONAL WARMING GELK040085PERSONAL WARMING LUBRICANTK973780PERSONAL LUBRICATING LIQUIDK973557LUBRIGLIDE

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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