K253112
- 510(k) number
- K253112
- Device name
- Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)
- Applicant
- Hlb Lifescience Co., Ltd. KR
- Product code
- FMF — Syringe, Piston
- Decision date
- 2026-05-21
- Date received
- 2025-09-24
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K253112.pdf
Official FDA record: K253112
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.