K-number	K153742
Device name	Apollo Balloon Dilatation Catheter
Applicant	Brosmed Medical Co., Ltd.
Product code	LOX
Device class	Class II
Decision date	Aug 8, 2016
Decision	Substantially Equivalent
Regulation	870.5100

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Source

View the full FDA submission: accessdata.fda.gov

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Apollo Balloon Dilatation Catheter

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