ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055

Lamp, Surgical

ST. FRANCIS MEDICAL EQUIPMENT CO., LTD.

The following data is part of a premarket notification filed by St. Francis Medical Equipment Co., Ltd. with the FDA for St. Francis Operating Theatre Lamp, Models Olh01-125 And Lc-055.

Pre-market Notification Details

Device IDK003423
510k NumberK003423
Device Name:ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055
ClassificationLamp, Surgical
Applicant ST. FRANCIS MEDICAL EQUIPMENT CO., LTD. P.O. BOX 129 SHIEN CHUANG 24299 Taipei Shien, Taiwan, R.o.c.,  TW
ContactFrancis Hong
CorrespondentFrancis Hong
ST. FRANCIS MEDICAL EQUIPMENT CO., LTD. P.O. BOX 129 SHIEN CHUANG 24299 Taipei Shien, Taiwan, R.o.c.,  TW
Product CodeFTD  
CFR Regulation Number878.4580 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-11-03
Decision Date2001-02-22

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