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FDA 510(k)

Agape Warming Personal Lubricant

K-Number: K200208 · 2020-04-27

ApplicantCC Wellness, LLC
Decision Date2020-04-27
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Agape Warming Personal Lubricant is a medical device manufactured by CC Wellness, LLC. It received FDA 510(k) clearance on 2020-04-27 under approval number K200208. 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 Warming Personal Lubricant?

Agape Warming Personal Lubricant is a medical device that received FDA 510(k) clearance on 2020-04-27. It is manufactured by CC Wellness, LLC. The 510(k) number is K200208.

When was Agape Warming Personal Lubricant approved by the FDA?

Agape Warming Personal Lubricant received FDA 510(k) clearance on 2020-04-27, under approval number K200208.

What company makes Agape Warming Personal Lubricant?

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

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

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

Other Devices by CC Wellness, LLC

K200894Agape Cooling Personal Lubricant K200602Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant K200457Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming 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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