FDA 510(k) Application Details - K041495

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K041495
Device Name	Set, Administration, Intravascular
Applicant	PENTAFERTE S.P.A LOC. NOCELLA STATALE 262 CAMPLI (TERAMO) 64012 IT Other 510(k) Applications for this Company
Contact	VITTORIO SERVIDORI 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	06/04/2004
Decision Date	04/15/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review