Name: Predicase
Price: 199 USD

K-number	K180764
Device name	TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant)
Applicant	Church & Dwight Co., Inc.
Product code	NUC
Device class	Class II
Decision date	Aug 1, 2018
Decision	Substantially Equivalent
Regulation	884.5300

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Source

View the full FDA submission: accessdata.fda.gov

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TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant)

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