FDA 510(k) Application Details - K001764

Device Classification Name	Warmer, Thermal, Infusion Fluid   More FDA Info for this Device
510(K) Number	K001764
Device Name	Warmer, Thermal, Infusion Fluid
Applicant	SIMS LEVEL 1, INC. 160 WEYMOUTH ST. ROCKLAND, MA 02370 US Other 510(k) Applications for this Company
Contact	GABRIEL J MURACA JR. 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	06/12/2000
Decision Date	08/09/2000
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