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.
Device ID | K003423 |
510k Number | K003423 |
Device Name: | ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055 |
Classification | Lamp, Surgical |
Applicant | ST. FRANCIS MEDICAL EQUIPMENT CO., LTD. P.O. BOX 129 SHIEN CHUANG 24299 Taipei Shien, Taiwan, R.o.c., TW |
Contact | Francis Hong |
Correspondent | Francis Hong ST. FRANCIS MEDICAL EQUIPMENT CO., LTD. P.O. BOX 129 SHIEN CHUANG 24299 Taipei Shien, Taiwan, R.o.c., TW |
Product Code | FTD |
CFR Regulation Number | 878.4580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-11-03 |
Decision Date | 2001-02-22 |