510(k) K152561 ยท FXX Mask, Surgical
Communicator Surgical Facemask with Clear Window
| Applicant | Prestige Ameritech , Ltd., North Richland Hills TX, US |
| Decision | Substantially Equivalent, Jun 3, 2016 |
| Received | Sep 9, 2015 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K152561
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.