Name: Predicase
Price: 199 USD

K-number	K110261
Device name	ENI-EYE SH TORIC (EFROFILCON A) SOFT HYDROPHILIC TORIC CONTACT LENS FOR DAILY WEAR, MULTIFOCAL CONTACT LENS, KERATOCONUS
Applicant	Soflex Limited
Product code	LPL
Device class	Class II
Decision date	Jul 28, 2011
Decision	Substantially Equivalent
Regulation	886.5925

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Source

View the full FDA submission: accessdata.fda.gov

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ENI-EYE SH TORIC (EFROFILCON A) SOFT HYDROPHILIC TORIC CONTACT LENS FOR DAILY WEAR, MULTIFOCAL CONTACT LENS, KERATOCONUS

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