FDA 510(k) Application Details - K062449

Device Classification Name	Injector, Contrast Medium, Automatic   More FDA Info for this Device
510(K) Number	K062449
Device Name	Injector, Contrast Medium, Automatic
Applicant	E-Z-EM, INC. 750 SUMMA AVE. WESTBURY, NY 11590 US Other 510(k) Applications for this Company
Contact	ROBERT WILLIAMS 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	08/22/2006
Decision Date	04/13/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review