FDA 510(k) Application Details - K082212

Device Classification Name	Injector And Syringe, Angiographic   More FDA Info for this Device
510(K) Number	K082212
Device Name	Injector And Syringe, Angiographic
Applicant	MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS 2111 EAST GALBRAITH RD. CINCINNATI, OH 45237 US Other 510(k) Applications for this Company
Contact	DALE MOORE 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	08/06/2008
Decision Date	01/22/2009
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