Name: Predicase
Price: 199 USD

K-number	K023333
Device name	MULTIPLE, MALE LATEX CONDOM [52MM OR 56MM NOMINAL WIDTH WITH SMOOTH OR DOTTED OR RIBBED OR 3 IN 1 (DOTTED/RIBBED/CONTOUR
Applicant	Pleasure Latex Products Sdn. Bhd.
Product code	HIS
Device class	Class II
Decision date	Jun 23, 2003
Decision	Substantially Equivalent
Regulation	884.5300

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Source

View the full FDA submission: accessdata.fda.gov

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MULTIPLE, MALE LATEX CONDOM [52MM OR 56MM NOMINAL WIDTH WITH SMOOTH OR DOTTED OR RIBBED OR 3 IN 1 (DOTTED/RIBBED/CONTOUR

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