| K-number | K202214 |
| Device name | IFM Surgical Mask Model SM3 |
| Applicant | Fssc, LLC |
| Product code | FXX |
| Device class | Class II |
| Decision date | Mar 2, 2021 |
| 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