K-number	K203541
Device name	Okamoto 002 Lubricated Polyurethane Male Condom
Applicant	Okamoto USA, Inc.
Product code	MOL
Device class	Class II
Decision date	Feb 25, 2022
Decision	Substantially Equivalent
Regulation	884.5300

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Source

View the full FDA submission: accessdata.fda.gov

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Okamoto 002 Lubricated Polyurethane Male Condom

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