FDA 510(k) Application Details - K093364

Device Classification Name	Pump, Infusion, Insulin   More FDA Info for this Device
510(K) Number	K093364
Device Name	Pump, Infusion, Insulin
Applicant	MEDINGO LTD. YOQNEAM INDUSTRIAL PARK BLDG.7 3RD FLOOR P.O. BOX 261 YOQNEAM 20692 IL Other 510(k) Applications for this Company
Contact	ARAVA HACOHEN 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	10/28/2009
Decision Date	01/25/2010
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