FDA 510(k) Application Details - K121363

Device Classification Name	Lamp, Infrared, Therapeutic Heating   More FDA Info for this Device
510(K) Number	K121363
Device Name	Lamp, Infrared, Therapeutic Heating
Applicant	TECHNOLOGICAL MEDICAL ADVANCMENTS, INC. (TMA) 1209 NORTH FLAGLER DRIVE WEST PALM BEACH, FL 33401 US Other 510(k) Applications for this Company
Contact	BRUCE COREN 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	05/07/2012
Decision Date	11/23/2012
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