Name: Predicase
Price: 199 USD

K-number	K010371
Device name	LIFESTYLES, CONTEMPO OR PRIVATE LABEL, MALE LATEX CONDOM WITH GLYCERINE LUBRICANT
Applicant	Suretex, Ltd.
Product code	HIS
Device class	Class II
Decision date	Apr 27, 2001
Decision	Substantially Equivalent
Regulation	884.5300

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Source

View the full FDA submission: accessdata.fda.gov

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LIFESTYLES, CONTEMPO OR PRIVATE LABEL, MALE LATEX CONDOM WITH GLYCERINE LUBRICANT

Everything you need for a 510(k) submission. Nothing you don't.