510(k) K161582 ยท FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
DORA Tubing Sets for Hemodialysis
| Applicant | Bain Medical Equipment (Guangzhou) Co., Ltd., Guangzhou, CN |
| Decision | Substantially Equivalent, Jun 16, 2017 |
| Received | Jun 8, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161582
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.