FDA 510(k) Application Details - K081720

Device Classification Name	Lamp, Infrared, Therapeutic Heating   More FDA Info for this Device
510(K) Number	K081720
Device Name	Lamp, Infrared, Therapeutic Heating
Applicant	PRIME HERBS CORPORATION 1872 HARTOG DRIVE SAN JOSE, CA 95131 US Other 510(k) Applications for this Company
Contact	GENEVIEVE HSIA 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	06/18/2008
Decision Date	06/16/2009
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