FDA 510(k) Application Details - K152361

Device Classification Name	Injector, Contrast Medium, Automatic   More FDA Info for this Device
510(K) Number	K152361
Device Name	Injector, Contrast Medium, Automatic
Applicant	Liebel-Flarsheim Company LLC 2111 East Galbraith Rd Cincinnati, OH 45237 US Other 510(k) Applications for this Company
Contact	Craig Buehler Other 510(k) Applications for this Contact
Regulation Number	870.1650   More FDA Info for this Regulation Number
Classification Product Code	IZQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/20/2015
Decision Date	01/14/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review