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FDA 510(k)

ally Warming Liquid Personal Lubricant

K-Number: K160717 · 2016-06-14

ApplicantPrivate Label Production, LLC
Decision Date2016-06-14
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ally Warming Liquid Personal Lubricant is the device name listed in this FDA 510(k) record. The listed applicant is Private Label Production, LLC. It received FDA 510(k) clearance on 2016-06-14 under 510(k) number K160717. 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 ally Warming Liquid Personal Lubricant?

ally Warming Liquid Personal Lubricant is a medical device that received FDA 510(k) clearance on 2016-06-14. The listed applicant is Private Label Production, LLC. The 510(k) number is K160717.

When did ally Warming Liquid Personal Lubricant receive FDA 510(k) clearance?

ally Warming Liquid Personal Lubricant received FDA 510(k) clearance on 2016-06-14, under 510(k) number K160717.

Who is the listed applicant for ally Warming Liquid Personal Lubricant?

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

What is the FDA product code for ally Warming Liquid Personal Lubricant?

The FDA product code for ally Warming Liquid Personal Lubricant is NUC.

Other records listing Private Label Production, 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.

K160763ally Liquid 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

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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