FDA 510(k) Application Details - K081355

Device Classification Name	Lamp, Infrared, Therapeutic Heating   More FDA Info for this Device
510(K) Number	K081355
Device Name	Lamp, Infrared, Therapeutic Heating
Applicant	MEDITECH INTERNATIONAL, INC. 411 HORNER AVE., UNIT #1 TORONTO, ONTARIO M8W 4W3 CA Other 510(k) Applications for this Company
Contact	FRED KAHN 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	05/14/2008
Decision Date	12/18/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review