FDA 510(k) Application Details - K091734

Device Classification Name	Injector, Contrast Medium, Automatic   More FDA Info for this Device
510(K) Number	K091734
Device Name	Injector, Contrast Medium, Automatic
Applicant	NEMOTO KYORINDO CO., LTD. 2-12-4 AOKI KAWAGUCHI-SHI, SAITAMA 332-0031 JP Other 510(k) Applications for this Company
Contact	MASAHIRO SAKAKIBARA 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	06/11/2009
Decision Date	05/21/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review