510(k) K131879 ยท FXX Mask, Surgical
KC 300 SURGICAL MASK
| Applicant | Kimberly-Clark Corp., Roswell GA, US |
| Decision | Substantially Equivalent, Dec 20, 2013 |
| Received | Jun 24, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131879
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 3, 2023 | Owens & Minor Distribution, Inc. FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor
Product Code 47147 Open, Classified |
FXX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.