K-number	K092495
Device name	HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4310, 104-4315
Applicant	Ev3 Neurovascular
Product code	MJN
Device class	Class II
Decision date	Sep 22, 2009
Decision	Substantially Equivalent
Regulation	870.4450

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HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4310, 104-4315

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