FDA 510(k) Application Details - K011811

Device Classification Name	Injector And Syringe, Angiographic   More FDA Info for this Device
510(K) Number	K011811
Device Name	Injector And Syringe, Angiographic
Applicant	MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. SOUTH JORDAN, UT 84095 US Other 510(k) Applications for this Company
Contact	DAN REIGLE 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	06/11/2001
Decision Date	08/22/2001
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