FDA 510(k) Application Details - K100504

Device Classification Name	Pump, Infusion, Insulin   More FDA Info for this Device
510(K) Number	K100504
Device Name	Pump, Infusion, Insulin
Applicant	VALERITAS, LLC 800 BOSTON TURNPIKE SHREWSBURY, MA 01545 US Other 510(k) Applications for this Company
Contact	SCOTT HUIE 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	02/22/2010
Decision Date	12/01/2010
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