510(k) K191643 ยท FMI Needle, Hypodermic, Single Lumen
TK Sterile Hypodermic Needle
| Applicant | Anhui Tiankang Medical Technology Co., Ltd., Tianchang, CN |
| Decision | Substantially Equivalent, Dec 19, 2019 |
| Received | Jun 19, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191643
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.