K-number	K092898
Device name	CONMED LINVATEC PRESTO PRELOADED WITH ONE OR TWO #2 HI-FI SUTURES
Applicant	Conmed Linvatec
Product code	MAI
Device class	Class II
Decision date	Oct 19, 2009
Decision	Substantially Equivalent
Regulation	888.3030

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Source

View the full FDA submission: accessdata.fda.gov

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CONMED LINVATEC PRESTO PRELOADED WITH ONE OR TWO #2 HI-FI SUTURES

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