Name: Predicase
Price: 199 USD

K-number	K050638
Device name	LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES
Applicant	Lenstec, Inc.
Product code	MSS
Device class	Class I
Decision date	May 31, 2005
Decision	Substantially Equivalent
Regulation	886.4300

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Source

View the full FDA submission: accessdata.fda.gov

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LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES

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