Name: Predicase
Price: 199 USD

K-number	K071203
Device name	SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL (SIHY) SOFT CONTACT LENSES
Applicant	Optikem International, Inc.
Product code	LPN
Device class	Class II
Decision date	Jun 13, 2007
Decision	Substantially Equivalent
Regulation	886.5928

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Source

View the full FDA submission: accessdata.fda.gov

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SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL (SIHY) SOFT CONTACT LENSES

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