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FDA 510(k)

Agape Cooling Personal Lubricant

K-Number: K200894 · 2020-07-02

ApplicantCC Wellness, LLC
Decision Date2020-07-02
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Agape Cooling Personal Lubricant is a medical device manufactured by CC Wellness, LLC. It received FDA 510(k) clearance on 2020-07-02 under approval number K200894. 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 Agape Cooling Personal Lubricant?

Agape Cooling Personal Lubricant is a medical device that received FDA 510(k) clearance on 2020-07-02. It is manufactured by CC Wellness, LLC. The 510(k) number is K200894.

When was Agape Cooling Personal Lubricant approved by the FDA?

Agape Cooling Personal Lubricant received FDA 510(k) clearance on 2020-07-02, under approval number K200894.

What company makes Agape Cooling Personal Lubricant?

Agape Cooling Personal Lubricant is manufactured by CC Wellness, LLC.

What is the FDA product code for Agape Cooling Personal Lubricant?

The FDA product code for Agape Cooling Personal Lubricant is NUC.

Other Devices by CC Wellness, LLC

K200602Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant K200457Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming K200208Agape Warming Personal Lubricant K210972H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To Tango for You, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Warming, #LubeLife Sensations Pleasure Kit for Two K210986H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, #LubeLife Sensations Cooling, #LubeLife Sensations Pleasure Kit for Two, JO 2 To Tango for Me, JO 2 To Tango Couples Pleasure Kit K221908JO CUMPLAY Personal Lubricant

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Related Devices (Code: NUC)

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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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