FDA 510(k) Application Details - K093830

Device Classification Name	Injector And Syringe, Angiographic   More FDA Info for this Device
510(K) Number	K093830
Device Name	Injector And Syringe, Angiographic
Applicant	MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE MUNDELEIN, IL 60060 US Other 510(k) Applications for this Company
Contact	MATT CLASEN Other 510(k) Applications for this Contact
Regulation Number	870.1650   More FDA Info for this Regulation Number
Classification Product Code	DXT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/14/2009
Decision Date	03/03/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review