Name: Predicase
Price: 199 USD

K-number	K052675
Device name	SYNERGEYES KC (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENS FOR KERATOCONUS
Applicant	Synergeyes
Product code	HQD
Device class	Class II
Decision date	Nov 30, 2005
Decision	Substantially Equivalent
Regulation	886.5916

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Source

View the full FDA submission: accessdata.fda.gov

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SYNERGEYES KC (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENS FOR KERATOCONUS

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