K-number	K080095
Device name	CORAMATE/SPIROTOME SYSTEM
Applicant	Medinvents
Product code	KNW
Device class	Class II
Decision date	Apr 11, 2008
Decision	Substantially Equivalent
Regulation	876.1075

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Source

View the full FDA submission: accessdata.fda.gov

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CORAMATE/SPIROTOME SYSTEM

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