Name: Predicase
Price: 199 USD

K-number	K080794
Device name	POLYVUE 55 SINGLE VISION, TORIC AND MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
Applicant	Polyvue Distribution, Inc.
Product code	LPL
Device class	Class II
Decision date	Dec 17, 2008
Decision	Substantially Equivalent
Regulation	886.5925

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Source

View the full FDA submission: accessdata.fda.gov

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POLYVUE 55 SINGLE VISION, TORIC AND MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR

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