FDA 510(k) Application Details - K100946

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K100946
Device Name	Set, Administration, Intravascular
Applicant	TERUMO EUROPE N.V. INTERLEUVENLAAN 40 LEUVEN 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	04/06/2010
Decision Date	08/02/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review