510(k) K173871 ยท NAJ Agents, Embolic, For Treatment Of Uterine Fibroids
CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres
| Applicant | Suzhou Hengrui Callisyn Biomedical Co., Ltd., Suzhou, CN |
| Decision | Substantially Equivalent, Sep 17, 2018 |
| Received | Dec 20, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173871
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.