K-number	K132383
Device name	GYRUS ACMI NEPHRO - EZDILATE NEPHROSTOMY BALLOON DILATION CATHETER
Applicant	Gyrus Acmi, Inc.
Product code	LJE
Device class	Class U
Decision date	Feb 4, 2014
Decision	Substantially Equivalent
Regulation	—

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GYRUS ACMI NEPHRO - EZDILATE NEPHROSTOMY BALLOON DILATION CATHETER

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