Name: Predicase
Price: 199 USD

K-number	K092586
Device name	MALE LATEX CONDOM (STRAIGHT SIDE OR CONTOURED OR FLARED IN SHAPE, EITHER TEXTURED OR NON-TEXTURED , LUBRICATED OR NON-LU
Applicant	Innolatex (Thailand) Limited
Product code	HIS
Device class	Class II
Decision date	May 12, 2010
Decision	Substantially Equivalent
Regulation	884.5300

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Source

View the full FDA submission: accessdata.fda.gov

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MALE LATEX CONDOM (STRAIGHT SIDE OR CONTOURED OR FLARED IN SHAPE, EITHER TEXTURED OR NON-TEXTURED , LUBRICATED OR NON-LU

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