K-number	K141256
Device name	OKAMOTO STUDDED CONDOM
Applicant	Okamoto USA, Inc.
Product code	HIS
Device class	Class II
Decision date	Jul 23, 2014
Decision	Substantially Equivalent
Regulation	884.5300

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Source

View the full FDA submission: accessdata.fda.gov

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OKAMOTO STUDDED CONDOM

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