510(k) K831148 ยท FXX Mask, Surgical
HIGH FILTRATION ISO-MASK
| Applicant | Tecnol New Jersey Wound Care, Inc., Walker MI, US |
| Decision | Substantially Equivalent, Jul 17, 1984 |
| Received | Apr 8, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K831148
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 20, 2024 | O&M HALYARD, INC. O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask
Product Code: 47117 Open, Classified |
FXX | None listed |
| Dec 20, 2024 | O&M HALYARD, INC. O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask
Product Code: 47500 Open, Classified |
FXX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.