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FDA 510(k)

Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant

K-Number: K200602 · 2020-06-03

ApplicantCC Wellness, LLC
Decision Date2020-06-03
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant is a medical device manufactured by CC Wellness, LLC. It received FDA 510(k) clearance on 2020-06-03 under approval number K200602. 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 Cooling Personal Lubricant, Premium Anal Cooling Lubricant?

Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant is a medical device that received FDA 510(k) clearance on 2020-06-03. It is manufactured by CC Wellness, LLC. The 510(k) number is K200602.

When was Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant approved by the FDA?

Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant received FDA 510(k) clearance on 2020-06-03, under approval number K200602.

What company makes Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant?

Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant is manufactured by CC Wellness, LLC.

What is the FDA product code for Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant?

The FDA product code for Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant 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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