K-number	K853296
Device name	EMODREN GUIDE NEEDLE FOR DRAINAGE TUBE & EMODREN
Applicant	Parexel Intl. Corp.
Product code	BYY
Device class	Class II
Decision date	Aug 15, 1985
Decision	Substantially Equivalent
Regulation	880.6740

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EMODREN GUIDE NEEDLE FOR DRAINAGE TUBE & EMODREN

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