Name: Predicase
Price: 199 USD

K-number	K200457
Device name	Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming
Applicant	CC Wellness, LLC
Product code	NUC
Device class	Class II
Decision date	May 22, 2020
Decision	Substantially Equivalent
Regulation	884.5300

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Source

View the full FDA submission: accessdata.fda.gov

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

Everything you need for a 510(k) submission. Nothing you don't.