K-number	K183679
Device name	Occlusion Balloon Catheter
Applicant	Qxmedical, LLC
Product code	MJN
Device class	Class II
Decision date	Apr 24, 2019
Decision	Substantially Equivalent
Regulation	870.4450

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Source

View the full FDA submission: accessdata.fda.gov

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Occlusion Balloon Catheter

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