FDA 510(k) Application Details - K971826

Device Classification Name	Controller, Infusion, Intravascular, Electronic   More FDA Info for this Device
510(K) Number	K971826
Device Name	Controller, Infusion, Intravascular, Electronic
Applicant	ALEXANDER MFG. CO. 1511 S GARFIELD PL MASON CITY, IA 50401 US Other 510(k) Applications for this Company
Contact	KEN HEIMENDINGER Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LDR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/16/1997
Decision Date	07/03/1997
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