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FDA 510(k)

Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming

K-Number: K200457 · 2020-05-22

ApplicantCC Wellness, LLC
Decision Date2020-05-22
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming is a medical device manufactured by CC Wellness, LLC. It received FDA 510(k) clearance on 2020-05-22 under approval number K200457. 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 Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming?

Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming is a medical device that received FDA 510(k) clearance on 2020-05-22. It is manufactured by CC Wellness, LLC. The 510(k) number is K200457.

When was Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming approved by the FDA?

Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming received FDA 510(k) clearance on 2020-05-22, under approval number K200457.

What company makes Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming?

Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming is manufactured by CC Wellness, LLC.

What is the FDA product code for Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming?

The FDA product code for Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming is 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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