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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name lamp, surgical
510(k) Number K003423
Device Name ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055
Applicant
ST. FRANCIS MEDICAL EQUIPMENT CO., LTD.
P.O. BOX 129
SHIEN CHUANG 24299
TAIPEI SHIEN, TAIWAN, R.O.C.,  TW
Applicant Contact FRANCIS HONG
Correspondent
ST. FRANCIS MEDICAL EQUIPMENT CO., LTD.
P.O. BOX 129
SHIEN CHUANG 24299
TAIPEI SHIEN, TAIWAN, R.O.C.,  TW
Correspondent Contact FRANCIS HONG
Regulation Number878.4580
Classification Product Code
FTD  
Date Received11/03/2000
Decision Date 02/22/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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