FDA 510(k) Application Details - K082765

Device Classification Name	Warmer, Thermal, Infusion Fluid   More FDA Info for this Device
510(K) Number	K082765
Device Name	Warmer, Thermal, Infusion Fluid
Applicant	STIHLER ELECTRONIC GMBH 30 NORTHPORT RD. SOUND BEACH, NY 11789-1734 US Other 510(k) Applications for this Company
Contact	STEPHEN T MLCOCH 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	09/22/2008
Decision Date	12/18/2008
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