Homtex, Inc. · Class II · Cleared Aug 19, 2021
| K-number | K211066 |
| Device name | Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask, Model Number: 2000SM3 |
| Applicant | Homtex, Inc. |
| Product code | FXX |
| Device class | Class II |
| Decision date | Aug 19, 2021 |
| Decision | Substantially Equivalent |
| Regulation | 878.4040 |
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