Name: Predicase
Price: 199 USD

K-number	K081178
Device name	OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSES
Applicant	Contamac, Ltd.
Product code	HQD
Device class	Class II
Decision date	Oct 9, 2008
Decision	Substantially Equivalent
Regulation	886.5916

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Source

View the full FDA submission: accessdata.fda.gov

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OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSES

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