510(k) K220662 ยท PEM Dental Barriers And Sleeves
Disposable Barrier Sleeves
| Applicant | Premium Plus (Dongguan) Limited, Dongguan, CN |
| Decision | Substantially Equivalent, May 11, 2022 |
| Received | Mar 7, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220662
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.