K-number	K024018
Device name	AVANT GUARDIAN 101
Applicant	Avant Medical Corporation
Product code	KZE
Device class	Class II
Decision date	Jan 17, 2003
Decision	Substantially Equivalent
Regulation	880.5430

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Source

View the full FDA submission: accessdata.fda.gov

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AVANT GUARDIAN 101

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