510(k) K190484 ยท PEM Dental Barriers And Sleeves
BH Medical Dental Barrier Sleeves and Barrier Film
| Applicant | Bh Medical Products Co., Ltd., Changzhou, CN |
| Decision | Substantially Equivalent, Sep 10, 2019 |
| Received | Feb 27, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190484
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.