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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 the device name listed in this FDA 510(k) record. The listed applicant is CC Wellness, LLC. It received FDA 510(k) clearance on 2020-05-22 under 510(k) 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. The listed applicant is CC Wellness, LLC. The 510(k) number is K200457.

When did Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming receive FDA 510(k) clearance?

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

Who is the listed applicant for Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming?

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

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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