FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055
K Number: K003423
·
Decision Feb 22, 2001
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
28
Applicant Total
1
Review Days
111
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Basic Information
- Device Name
- ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055
- K Number
- K003423
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4580
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- St. Francis Medical Equipment Co., Ltd.
- Date Received
- November 3, 2000
- Decision Date
- February 22, 2001
- Product Code
- FTD
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FTD | Lamp, Surgical | FDA class 2 | General, Plastic Surgery |
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