FDA 510(k) Application Details - K990233

Device Classification Name	Lamp, Infrared, Therapeutic Heating   More FDA Info for this Device
510(K) Number	K990233
Device Name	Lamp, Infrared, Therapeutic Heating
Applicant	SKYLARK DEVICE CO., LTD. 12FL, 34, SEC. 3 CHUNG SHAN N. ROAD TAIPEI TW Other 510(k) Applications for this Company
Contact	GEORGE K. C CHEN 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	01/25/1999
Decision Date	10/27/1999
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