K-number	K971132
Device name	ROYALE BRAND LATEX CONDOMS (SILICONE)-COLORED/ASSORTED COLORS
Applicant	G. Premjee (Usa), Inc.
Product code	HIS
Device class	Class II
Decision date	Sep 3, 1997
Decision	Substantially Equivalent
Regulation	884.5300

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ROYALE BRAND LATEX CONDOMS (SILICONE)-COLORED/ASSORTED COLORS

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