FDA 510(k) Application Details - K071691

Device Classification Name	Injector And Syringe, Angiographic   More FDA Info for this Device
510(K) Number	K071691
Device Name	Injector And Syringe, Angiographic
Applicant	NEMOTO KYORINDO CO., LTD. 24992 DEL MONTE ST. LAGUNA HILLS, CA 92653-5617 US Other 510(k) Applications for this Company
Contact	MICHAEL HIEDA 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	06/20/2007
Decision Date	12/19/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review