FDA 510(k) Application Details - K052744

Device Classification Name	Injector And Syringe, Angiographic   More FDA Info for this Device
510(K) Number	K052744
Device Name	Injector And Syringe, Angiographic
Applicant	ACIST MEDICAL SYSTEMS, INC. 7450 FLYING CLOUD DR. SUITE 150 EDEN PRAIRIE, MN 55344 US Other 510(k) Applications for this Company
Contact	A; SAALABI 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	09/30/2005
Decision Date	12/16/2005
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