FDA 510(k) Application Details - K093332

Device Classification Name	Pump, Infusion   More FDA Info for this Device
510(K) Number	K093332
Device Name	Pump, Infusion
Applicant	DELPHI MEDICAL SYSTEMS 5725 DELPHI DR TROY, MI 48098 US Other 510(k) Applications for this Company
Contact	GILBERT ROQUE JR. 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	10/26/2009
Decision Date	12/09/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review