K-number	K131092
Device name	STEALTH 360 ORBITAL PAD SYSTEM
Applicant	Cardio Systems, Inc.
Product code	MCW
Device class	Class II
Decision date	Jun 24, 2013
Decision	Substantially Equivalent
Regulation	870.4875

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Source

View the full FDA submission: accessdata.fda.gov

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STEALTH 360 ORBITAL PAD SYSTEM

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