510(k) K171162 ยท FXX Mask, Surgical
Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield
| Applicant | Prestige Ameritech, North Richland Hills TX, US |
| Decision | Substantially Equivalent, Aug 15, 2017 |
| Received | Apr 20, 2017 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K171162
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.