FDA 510(k) Application Details - K020418

Device Classification Name	Pump, Infusion, Pca   More FDA Info for this Device
510(K) Number	K020418
Device Name	Pump, Infusion, Pca
Applicant	P.T. GREENLEAF 25 SHANN ST., FLOREAT PERTH, WESTERN AUSTRALIA 6014 AU Other 510(k) Applications for this Company
Contact	GEORGE O'NEIL Other 510(k) Applications for this Contact
Regulation Number	880.5725   More FDA Info for this Regulation Number
Classification Product Code	MEA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/07/2002
Decision Date	04/29/2003
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