Name: Predicase
Price: 199 USD

K-number	K020608
Device name	HD/HDT, (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY CAST-MOLDED LENS)
Applicant	Poly Vue Technolgies, Inc.
Product code	LPL
Device class	Class II
Decision date	May 16, 2002
Decision	Substantially Equivalent
Regulation	886.5925

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Source

View the full FDA submission: accessdata.fda.gov

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HD/HDT, (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY CAST-MOLDED LENS)

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