510(k) K151123 ยท PEM Dental Barriers And Sleeves
Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film
| Applicant | Pac-Dent International, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Mar 3, 2016 |
| Received | Apr 28, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151123
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.