Name: Predicase
Price: 199 USD

K-number	K160938
Device name	SynergEyes SiH with Hydra-PEG(petrafocon A hem-larafilcon A) Hybrid Daily Wear Lens
Applicant	Synergeyes, Inc.
Product code	HQD
Device class	Class II
Decision date	Aug 1, 2016
Decision	Substantially Equivalent
Regulation	886.5916

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Source

View the full FDA submission: accessdata.fda.gov

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SynergEyes SiH with Hydra-PEG(petrafocon A hem-larafilcon A) Hybrid Daily Wear Lens

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