FDA 510(k) Application Details - K080174

Device Classification Name	Set, I.V. Fluid Transfer   More FDA Info for this Device
510(K) Number	K080174
Device Name	Set, I.V. Fluid Transfer
Applicant	CARDIOMED SUPPLIES, INC. 199 ST. DAVID STREET LINDSAY-ONTARIO K9V 5K7 CA Other 510(k) Applications for this Company
Contact	CHRISTIAN G DUBE Other 510(k) Applications for this Contact
Regulation Number	880.5440   More FDA Info for this Regulation Number
Classification Product Code	LHI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/24/2008
Decision Date	04/23/2008
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