Name: Predicase
Price: 199 USD

K-number	K091458
Device name	HYPERGLIDE OCCLUSION BALLOON SYSTEM, HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4112, 104-4113, 104-4127,104-4132,104
Applicant	Ev3 Neurovascular
Product code	MJN
Device class	Class II
Decision date	Oct 15, 2009
Decision	Substantially Equivalent
Regulation	870.4450

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View the full FDA submission: accessdata.fda.gov

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HYPERGLIDE OCCLUSION BALLOON SYSTEM, HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4112, 104-4113, 104-4127,104-4132,104

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