FDA 510(k) Application Details - K060316

Device Classification Name	Pump, Infusion, Enteral   More FDA Info for this Device
510(K) Number	K060316
Device Name	Pump, Infusion, Enteral
Applicant	FRESENIUS KABI DEUTSCHLAND GMBH DAIMLERSTRASSE 22 BAD HOMBURG D-61352 DE Other 510(k) Applications for this Company
Contact	BARBARA BREUER-THAL Other 510(k) Applications for this Contact
Regulation Number	880.5725   More FDA Info for this Regulation Number
Classification Product Code	LZH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/08/2006
Decision Date	06/23/2006
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