Name: Predicase
Price: 199 USD

K-number	K234099
Device name	Select Hybrid Personal Lubricant, and Select Pure Silicone Personal Lubricant
Applicant	Select Labs, LLC
Product code	NUC
Device class	Class II
Decision date	Jun 7, 2024
Decision	Substantially Equivalent
Regulation	884.5300

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Source

View the full FDA submission: accessdata.fda.gov

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Select Hybrid Personal Lubricant, and Select Pure Silicone Personal Lubricant

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