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 |