K-number	K082529
Device name	ALATECH CHAMPION VYTEX LUBRICATED MALE LATEX CONDOM
Applicant	Alatech Healthcare, LLC
Product code	HIS
Device class	Class II
Decision date	May 1, 2009
Decision	Substantially Equivalent
Regulation	884.5300

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View the full FDA submission: accessdata.fda.gov

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ALATECH CHAMPION VYTEX LUBRICATED MALE LATEX CONDOM

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