510(k) K253112 ยท FMF Syringe, Piston
Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)
| Applicant | Hlb Lifescience Co., Ltd., Anseong-Si, KR |
| Decision | Substantially Equivalent, May 21, 2026 |
| Received | Sep 24, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K253112
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.