FDA 510(k) Application Details - K100567

Device Classification Name	Pump, Infusion, Insulin   More FDA Info for this Device
510(K) Number	K100567
Device Name	Pump, Infusion, Insulin
Applicant	M2 GROUP HOLDINGS, INC. 1012 STEWART DRIVE SUNNYVALE, CA 94085 US Other 510(k) Applications for this Company
Contact	NAGHMEH NOURI 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	03/01/2010
Decision Date	05/10/2011
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