FDA 510(k) Application Details - K010390

Device Classification Name	Injector And Syringe, Angiographic   More FDA Info for this Device
510(K) Number	K010390
Device Name	Injector And Syringe, Angiographic
Applicant	ACIST MEDICAL SYSTEMS, INC. 7450 FLYING CLOUDS DR. SUITE 150 EDEN PRAIRIE, MN 55344 US Other 510(k) Applications for this Company
Contact	CARL M BEAURLINE 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	02/09/2001
Decision Date	03/09/2001
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