FDA 510(k) Application Details - K021080

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K021080
Device Name	Set, Administration, Intravascular
Applicant	CARDIOMED SUPPLIES, INC. 5 GORMLEY INDUSTRIAL AVENUE GORMLEY, ONTARIO L0H 1G0 CA Other 510(k) Applications for this Company
Contact	DONNA MCCOMB Other 510(k) Applications for this Contact
Regulation Number	880.5440   More FDA Info for this Regulation Number
Classification Product Code	FPA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/03/2002
Decision Date	08/29/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review