FDA 510(k) Application Details - K080297

Device Classification Name	Pump, Infusion   More FDA Info for this Device
510(K) Number	K080297
Device Name	Pump, Infusion
Applicant	MEDRAD, INC. ONE MEDRAD DR. INDIANOLA, PA 15051 US Other 510(k) Applications for this Company
Contact	TROY A JACK 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	02/04/2008
Decision Date	06/17/2008
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