510(k) K163025 ยท FIE Needle, Fistula
DORA Disposable A.V. Fistula Needle Sets
| Applicant | Bain Medical Equipment (Guangzhou) Co., Ltd., Guangzhou, CN |
| Decision | Substantially Equivalent, Jul 20, 2017 |
| Received | Oct 31, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163025
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.