FDA 510(k) Application Details - K080689

Device Classification Name	Lamp, Infrared, Therapeutic Heating   More FDA Info for this Device
510(K) Number	K080689
Device Name	Lamp, Infrared, Therapeutic Heating
Applicant	PREMIER DYNAMICS, INC. 3863 ROCHESTER ROAD TROY, MI 48083 US Other 510(k) Applications for this Company
Contact	JOHN J STEPHAN 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	03/11/2008
Decision Date	07/09/2008
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