FDA 510(k) Application Details - K062644

Device Classification Name	Warmer, Thermal, Infusion Fluid   More FDA Info for this Device
510(K) Number	K062644
Device Name	Warmer, Thermal, Infusion Fluid
Applicant	MERLYN ASSOCIATES, INC. 1542 EDINGER AVE., SUITE A TUSTIN, CA 92780 US Other 510(k) Applications for this Company
Contact	KAREN CHEN 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	09/06/2006
Decision Date	09/11/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review