K243533
- 510(k) number
- K243533
- Device name
- Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus
- Applicant
- Hlb Co., Ltd. Healthcare KR
- Product code
- FMK — Single Use Only Blood Lancet With An Integral Sharps
- Decision date
- 2025-01-13
- Date received
- 2024-11-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K243533.pdf
Official FDA record: K243533
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.