510(k) K232165 ยท FMI Needle, Hypodermic, Single Lumen
Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles; Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles
| Applicant | Berpu Medical Technology Co., Ltd., Wenzhou, CN |
| Decision | Substantially Equivalent, Feb 1, 2024 |
| Received | Jul 21, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232165
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.