FDA 510(k) Application Details - K962159

Device Classification Name	Accessories, Pump, Infusion   More FDA Info for this Device
510(K) Number	K962159
Device Name	Accessories, Pump, Infusion
Applicant	FAULDING MEDICAL DEVICE CO. 8777 EAST VIA DE VENTURA, SUITE 225 SCOTTSDALE, AZ 85258 US Other 510(k) Applications for this Company
Contact	BRUCE CRANEY Other 510(k) Applications for this Contact
Regulation Number	880.5725   More FDA Info for this Regulation Number
Classification Product Code	MRZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/04/1996
Decision Date	07/18/1997
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