Name: Predicase
Price: 199 USD

K-number	K984259
Device name	PROSTHETIC (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)
Applicant	Cl-Tinters
Product code	LPL
Device class	Class II
Decision date	Jan 21, 1999
Decision	Substantially Equivalent
Regulation	886.5925

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Source

View the full FDA submission: accessdata.fda.gov

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

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