K-number	K991929
Device name	INTRASTENT
Applicant	Intratherapeutics, Inc.
Product code	FGE
Device class	Class II
Decision date	Aug 4, 1999
Decision	Unknown
Regulation	876.5010

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Source

View the full FDA submission: accessdata.fda.gov

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INTRASTENT

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