FDA 510(k) Application Details - K043306

Device Classification Name	Lamp, Infrared, Therapeutic Heating   More FDA Info for this Device
510(K) Number	K043306
Device Name	Lamp, Infrared, Therapeutic Heating
Applicant	SKYLARK DEVICE & SYSTEMS CO., LTD 4F, 34, SEC. 3, CHUNG SHAN NORTH RD. TAIPEI 104 TW Other 510(k) Applications for this Company
Contact	BETTY CHIEN 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	12/01/2004
Decision Date	06/06/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review