FDA 510(k) Application Details - K070584

Device Classification Name	Set, I.V. Fluid Transfer   More FDA Info for this Device
510(K) Number	K070584
Device Name	Set, I.V. Fluid Transfer
Applicant	DUOJECT MEDICAL SYSTEMS, INC. 50 CHEMIN DE GASPE COMPLEX B-5 BROMONT J2L 2N8 CA Other 510(k) Applications for this Company
Contact	CAROLINE LAVOIE 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	03/01/2007
Decision Date	04/02/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review