510(k) K191034 ยท ELW Material, Impression
VPS Impression Material
| Applicant | Hygedent, Inc., Beijing, CN |
| Decision | Substantially Equivalent, Sep 4, 2019 |
| Received | Apr 18, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191034
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.