Fomed Industries, Inc. · Class II · Cleared Apr 25, 2022
| K-number | K220512 |
| Device name | Disposable Surgical Face Mask (M01, M02) |
| Applicant | Fomed Industries, Inc. |
| Product code | FXX |
| Device class | Class II |
| Decision date | Apr 25, 2022 |
| Decision | Substantially Equivalent |
| Regulation | 878.4040 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov