FDA 510(k) Application Details - K100947

Device Classification Name	Pump, Infusion, Insulin Bolus   More FDA Info for this Device
510(K) Number	K100947
Device Name	Pump, Infusion, Insulin Bolus
Applicant	CALIBRA MEDICAL, INC. 220 SAGINAW DRIVE REDWOOD CITY, CA 94063 US Other 510(k) Applications for this Company
Contact	RICHARD J MEADER Other 510(k) Applications for this Contact
Regulation Number	880.5725   More FDA Info for this Regulation Number
Classification Product Code	OPP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/06/2010
Decision Date	06/28/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review