K-number	K842113
Device name	AMENDMENT TO ANGIOGRAPHY KIT W/ADDIT
Applicant	Mallinckrodt Critical Care
Product code	DRE
Device class	Class II
Decision date	Jul 13, 1984
Decision	Substantially Equivalent
Regulation	870.1310

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View the full FDA submission: accessdata.fda.gov

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AMENDMENT TO ANGIOGRAPHY KIT W/ADDIT

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