K-number	K133852
Device name	APOLLO BALLOON DILATATION CATHETER
Applicant	Brosmed Medical
Product code	LOX
Device class	Class II
Decision date	Sep 19, 2014
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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