FDA 510(k) Application Details - K063568

Device Classification Name	Lamp, Infrared, Therapeutic Heating   More FDA Info for this Device
510(K) Number	K063568
Device Name	Lamp, Infrared, Therapeutic Heating
Applicant	SUZHOU MEDICAL APPLIANCE FACTORY 1491 BAKER ST. SUITE 1 COSTA MESA, CA 92626 US Other 510(k) Applications for this Company
Contact	HENRY WOO Other 510(k) Applications for this Contact
Regulation Number	890.5500   More FDA Info for this Regulation Number
Classification Product Code	ILY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/28/2006
Decision Date	03/22/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review