FDA 510(k) Application Details - K083221

Device Classification Name	Accessories, Pump, Infusion   More FDA Info for this Device
510(K) Number	K083221
Device Name	Accessories, Pump, Infusion
Applicant	AIDERA AB MEDICINAREGATAN 8A GOTEBORG SE 413 46 SE Other 510(k) Applications for this Company
Contact	ANDERS SONESSON Other 510(k) Applications for this Contact
Regulation Number	880.5725   More FDA Info for this Regulation Number
Classification Product Code	MRZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/31/2008
Decision Date	02/03/2009
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	N
Expedited Review