FDA 510(k) Application Details - K100798

Device Classification Name	Pump, Infusion   More FDA Info for this Device
510(K) Number	K100798
Device Name	Pump, Infusion
Applicant	MEDRAD, INC. ONE MEDRAD DR. INDIANOLA, PA 15051 US Other 510(k) Applications for this Company
Contact	SUSAN LYNN FELIX 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	03/22/2010
Decision Date	06/23/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review