FDA 510(k) Application Details - K050312

Device Classification Name	Pump, Infusion, Insulin   More FDA Info for this Device
510(K) Number	K050312
Device Name	Pump, Infusion, Insulin
Applicant	NIPRO DIABETES SYSTEMS, INC. 3361 ENTERPRISE WAY MIRAMAR, FL 33025 US Other 510(k) Applications for this Company
Contact	CLARENCE ODOM Other 510(k) Applications for this Contact
Regulation Number	880.5725   More FDA Info for this Regulation Number
Classification Product Code	LZG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/08/2005
Decision Date	05/09/2005
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