510(k) K201421 ยท FXX Mask, Surgical
Dukal Corporation Level 2 Surgical Mask with Ear Loops; Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield; Dukal Corporation Level 2 Surgical Mask with Adjustable Tie Ons
| Applicant | Dukal Corporation, Ronkonkoma NY, US |
| Decision | Substantially Equivalent, Feb 5, 2021 |
| Received | May 29, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201421
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.