K-number	K100793
Device name	UROSTATION 3D PROSTATE SUITE
Applicant	Koelis
Product code	LLZ
Device class	Class II
Decision date	Sep 22, 2010
Decision	Substantially Equivalent
Regulation	892.2050

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View the full FDA submission: accessdata.fda.gov

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UROSTATION 3D PROSTATE SUITE

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