K-number	K171575
Device name	ENFLU 18 (enflufocon A) Daily Wear Contact Lens
Applicant	Contamac, Ltd.
Product code	HQD
Device class	Class II
Decision date	Oct 24, 2017
Decision	Substantially Equivalent
Regulation	886.5916

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Source

View the full FDA submission: accessdata.fda.gov

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ENFLU 18 (enflufocon A) Daily Wear Contact Lens

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