Owens & Minor (O&M) Halyard, Inc. · Class II · Cleared Jan 12, 2024
| K-number | K233022 |
| Device name | Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small |
| Applicant | Owens & Minor (O&M) Halyard, Inc. |
| Product code | MSH |
| Device class | Class II |
| Decision date | Jan 12, 2024 |
| Decision | Substantially Equivalent |
| Regulation | 878.4040 |
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