510(k) K183263 ยท PEM Dental Barriers And Sleeves
UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope
| Applicant | Unipack Medical Corporation, Santa Fe Springs CA, US |
| Decision | Substantially Equivalent, Jun 14, 2019 |
| Received | Nov 23, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183263
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.