510(k) K190949 ยท PEM Dental Barriers And Sleeves
ScanX Barrier Envelopes
| Applicant | Air Techniques, Inc., Melville NY, US |
| Decision | Substantially Equivalent, Jul 26, 2019 |
| Received | Apr 11, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190949
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.