FDA 510(k) Application Details - K061976

Device Classification Name	Injector And Syringe, Angiographic   More FDA Info for this Device
510(K) Number	K061976
Device Name	Injector And Syringe, Angiographic
Applicant	TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. P.O. BOX 2068 TUSTIN, CA 92781-2068 US Other 510(k) Applications for this Company
Contact	PAUL BIGGINS 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	07/13/2006
Decision Date	09/27/2006
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	Y
Expedited Review