K-number	K120573
Device name	MEDART 620
Applicant	Medart A/S
Product code	GEX
Device class	Class II
Decision date	Jun 13, 2012
Decision	Substantially Equivalent
Regulation	878.4810

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Source

View the full FDA submission: accessdata.fda.gov

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MEDART 620

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