K-number	K150951
Device name	aeris Balloon Dialation Catheter
Applicant	Bryan Medical, Inc.
Product code	KTI
Device class	Class II
Decision date	Jun 25, 2015
Decision	Substantially Equivalent
Regulation	874.4680

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View the full FDA submission: accessdata.fda.gov

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aeris Balloon Dialation Catheter

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