FDA 510(k) Application Details - K052887

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K052887
Device Name	Set, Administration, Intravascular
Applicant	TERUMO EUROPE N.V. RESEARCHPARK ZONE 2 INTERLEUVENLAAN 40 LEUVEN 3001 3001 BE Other 510(k) Applications for this Company
Contact	M.J. AERTS 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	10/13/2005
Decision Date	12/08/2005
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