FDA 510(k) Application Details - K033208

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K033208
Device Name	Set, Administration, Intravascular
Applicant	IVY DEVICES, INC. P.O. BOX 23241 GRANDE PRAIRIE, ALBERTA T8V 6X2 CA Other 510(k) Applications for this Company
Contact	WILLIAM REILLY 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	10/02/2003
Decision Date	03/18/2004
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