K-number	K063795
Device name	GUARDIANCATHETER-URINARY DRAINAGE CATHETER
Applicant	Marian Medical, Inc.
Product code	GBM
Device class	Class II
Decision date	Mar 5, 2007
Decision	Substantially Equivalent
Regulation	876.5130

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View the full FDA submission: accessdata.fda.gov

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GUARDIANCATHETER-URINARY DRAINAGE CATHETER

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