K-number	K111881
Device name	VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT
Applicant	Coloplast A/S
Product code	OTM
Device class	Class II
Decision date	Aug 17, 2011
Decision	Substantially Equivalent
Regulation	878.3300

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View the full FDA submission: accessdata.fda.gov

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VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT

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