K-number	K182438
Device name	Synthetic Polyisoprene Lubricated Male Condom - 5 senses
Applicant	Sxwell USA, LLC
Product code	MOL
Device class	Class II
Decision date	Dec 6, 2018
Decision	Substantially Equivalent
Regulation	884.5300

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Source

View the full FDA submission: accessdata.fda.gov

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Synthetic Polyisoprene Lubricated Male Condom - 5 senses

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