Name: Predicase
Price: 199 USD

K-number	K971049
Device name	FREQUENCY 38 (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)
Applicant	Aspect Vision Care, Ltd.
Product code	LPL
Device class	Class II
Decision date	May 21, 1997
Decision	Substantially Equivalent
Regulation	886.5925

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Source

View the full FDA submission: accessdata.fda.gov

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FREQUENCY 38 (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)

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