K-number	K960315
Device name	FLAVORED LATEX PATIENT EXAMINATION
Applicant	P.T. Irama Dinamika Latex
Product code	LYY
Device class	Class I
Decision date	Nov 20, 1996
Decision	Substantially Equivalent
Regulation	880.6250

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View the full FDA submission: accessdata.fda.gov

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FLAVORED LATEX PATIENT EXAMINATION

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