K-number	K942578
Device name	ENTRAC URETERAL BALLOON DILATATION CATHETERS
Applicant	American Medical Systems, Inc.
Product code	EZN
Device class	Class II
Decision date	Aug 19, 1994
Decision	Substantially Equivalent
Regulation	876.5470

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ENTRAC URETERAL BALLOON DILATATION CATHETERS

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