510(k) K190002 ยท FMF Syringe, Piston
Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use
| Applicant | Shanghai Kohope Medical Devices Co., Ltd., Shanghai, CN |
| Decision | Substantially Equivalent, Sep 12, 2019 |
| Received | Jan 2, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190002
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.