510(k) K974068 ยท MSH Respirator, Surgical
PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL
| Applicant | Tecnol Medical Products, Inc., Fort Worth TX, US |
| Decision | Substantially Equivalent, Dec 22, 1997 |
| Received | Oct 28, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974068
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 21, 2023 | O&M HALYARD, INC. FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code 46827 Open, Classified |
MSH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.