K-number	K143613
Device name	PaxWire Occlusion Balloon System
Applicant	Accessclosure, Inc.
Product code	MJN
Device class	Class II
Decision date	Aug 14, 2015
Decision	Substantially Equivalent
Regulation	870.4450

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Source

View the full FDA submission: accessdata.fda.gov

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PaxWire Occlusion Balloon System

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