Name: Predicase
Price: 199 USD

K-number	K061157
Device name	SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS
Applicant	Bausch & Lomb
Product code	MVN
Device class	Class II
Decision date	Jun 22, 2006
Decision	Substantially Equivalent
Regulation	886.5925

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Source

View the full FDA submission: accessdata.fda.gov

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SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS

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