510(k) K213535 ยท FMI Needle, Hypodermic, Single Lumen
Sterile Safety Hypodermic Needles for Single Use
| Applicant | Zhejiang Kangkang Medical-Devices Co., Ltd., Yuhuan, CN |
| Decision | Substantially Equivalent, May 13, 2022 |
| Received | Nov 5, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213535
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.