510(k) K163447 ยท PEM Dental Barriers And Sleeves
Premium Plus Disposable Barrier Sleeve
| Applicant | Premium Plus International Limited, Hong Kong, CN |
| Decision | Substantially Equivalent, Jun 20, 2017 |
| Received | Dec 8, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163447
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.