FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
SG Lanset I, SG Lancets, Soft Lancets
K Number: K230712
·
Decision Dec 6, 2023
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
15
Applicant Total
1
Review Days
266
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Basic Information
- Device Name
- SG Lanset I, SG Lancets, Soft Lancets
- K Number
- K230712
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4850
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sewon Medical Co.
- Date Received
- March 15, 2023
- Decision Date
- December 6, 2023
- Product Code
- QRK
- 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 |
|---|---|---|---|
| QRK | Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | FDA class 2 | General, Plastic Surgery |
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