Name: Predicase
Price: 199 USD

K-number	K972836
Device name	ROYALE BRAND LATEX CONDOMS-SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS
Applicant	G. Premjee (Usa), Inc.
Product code	LTZ
Device class	Class II
Decision date	Oct 22, 1997
Decision	Substantially Equivalent
Regulation	884.5310

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Source

View the full FDA submission: accessdata.fda.gov

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ROYALE BRAND LATEX CONDOMS-SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS

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