K-number	K131229
Device name	SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS
Applicant	American Medical Systems
Product code	OTN
Device class	Class II
Decision date	Dec 5, 2013
Decision	Substantially Equivalent
Regulation	878.3300

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View the full FDA submission: accessdata.fda.gov

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SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS

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