Name: Predicase
Price: 199 USD

K-number	K152657
Device name	SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens
Applicant	Smart Performer Corp. , Ltd.
Product code	LPL
Device class	Class II
Decision date	May 17, 2016
Decision	Substantially Equivalent
Regulation	886.5925

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Source

View the full FDA submission: accessdata.fda.gov

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SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens

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