Name: Predicase
Price: 199 USD

K-number	K120555
Device name	LATEX MALE CONDOM (SMOOTH SURFACE) LATEX MALE CONDOM (TEXTURED SURFACE)
Applicant	Medical-Latex (Dua) Sdn. Bhd
Product code	HIS
Device class	Class II
Decision date	Nov 2, 2012
Decision	Substantially Equivalent
Regulation	884.5300

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Source

View the full FDA submission: accessdata.fda.gov

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LATEX MALE CONDOM (SMOOTH SURFACE) LATEX MALE CONDOM (TEXTURED SURFACE)

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