K-number	K953954
Device name	PRELOADED SOFT TISSUE ANCHOR
Applicant	Linvatec Corp.
Product code	MBI
Device class	Class II
Decision date	Feb 20, 1996
Decision	Substantially Equivalent for Some Indications
Regulation	888.3040

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Source

View the full FDA submission: accessdata.fda.gov

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PRELOADED SOFT TISSUE ANCHOR

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