Name: Predicase
Price: 199 USD

K-number	K143431
Device name	Giselle (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted)
Applicant	I-Codi Co., Ltd.
Product code	LPL
Device class	Class II
Decision date	Feb 20, 2015
Decision	Substantially Equivalent
Regulation	886.5925

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Source

View the full FDA submission: accessdata.fda.gov

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Giselle (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted)

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