K-number	K012374
Device name	MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETER
Applicant	Astra Tech, Inc.
Product code	GBM
Device class	Class II
Decision date	Aug 23, 2001
Decision	Substantially Equivalent
Regulation	876.5130

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MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETER

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