FDA 510(k) Application Details - K003423

Device Classification Name	Lamp, Surgical   More FDA Info for this Device
510(K) Number	K003423
Device Name	Lamp, Surgical
Applicant	ST. FRANCIS MEDICAL EQUIPMENT CO., LTD. P.O. BOX 129 SHIEN CHUANG 24299 TAIPEI SHIEN, TAIWAN, R.O.C. TW Other 510(k) Applications for this Company
Contact	FRANCIS HONG Other 510(k) Applications for this Contact
Regulation Number	878.4580   More FDA Info for this Regulation Number
Classification Product Code	FTD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/03/2000
Decision Date	02/22/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review