Name: Predicase
Price: 199 USD

K-number	K191480
Device name	Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid)
Applicant	Trigg Laboratories, Inc. D/B/A Wet International
Product code	NUC
Device class	Class II
Decision date	Oct 11, 2019
Decision	Substantially Equivalent
Regulation	884.5300

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Source

View the full FDA submission: accessdata.fda.gov

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Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid)

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