K230712
- 510(k) number
- K230712
- Device name
- SG Lanset I, SG Lancets, Soft Lancets
- Applicant
- Sewon Medical Co. KR
- Product code
- QRK — Single Use Only Blood Lancet Without An Integral Sha
- Decision date
- 2023-12-06
- Date received
- 2023-03-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K230712.pdf
Official FDA record: K230712
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.