FDA 510(k) Application Details - K060537

Device Classification Name	Warmer, Thermal, Infusion Fluid   More FDA Info for this Device
510(K) Number	K060537
Device Name	Warmer, Thermal, Infusion Fluid
Applicant	ENGINIVITY LLC 8 GRAY LODGE ROAD KITTERY, ME 03904 US Other 510(k) Applications for this Company
Contact	PENELOPE GRECO Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LGZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/28/2006
Decision Date	06/08/2006
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