FDA 510(k) Application Details - K020424

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K020424
Device Name	Set, Administration, Intravascular
Applicant	HENNIG ENTERPRISES EUROPE S.R.L. 25 SHANN ST., FLOREAT PERTH 6014 AU Other 510(k) Applications for this Company
Contact	GEORGE O'NEIL 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	02/08/2002
Decision Date	08/29/2003
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