K-number	K043241
Device name	LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER
Applicant	Astra Tech, Inc.
Product code	GBM
Device class	Class II
Decision date	Dec 23, 2004
Decision	Substantially Equivalent
Regulation	876.5130

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View the full FDA submission: accessdata.fda.gov

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LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER

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