FDA 510(k) Application Details - K980378

Device Classification Name	Pump, Infusion   More FDA Info for this Device
510(K) Number	K980378
Device Name	Pump, Infusion
Applicant	COMPAGNIE DE DEVELOPPEMENT AGUETTANT 700 THIRTEENTH ST. N.W. SUITE 1200 WASHINGTON, DC 20005 US Other 510(k) Applications for this Company
Contact	DIANE MCCOLL Other 510(k) Applications for this Contact
Regulation Number	880.5725   More FDA Info for this Regulation Number
Classification Product Code	FRN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/30/1998
Decision Date	12/09/1998
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