The following data is part of a premarket notification filed by Homtex, Inc. with the FDA for Sovereign America Surgical Face Mask.
| Device ID | K201095 |
| 510k Number | K201095 |
| Device Name: | Sovereign America Surgical Face Mask |
| Classification | Mask, Surgical |
| Applicant | HomTex, Inc. 2125 2nd Avenue SW Cullman, AL 35055 |
| Contact | Jeremy Wootten |
| Correspondent | Jeremy Wootten HomTex, Inc. 2125 2nd Avenue SW Cullman, AL 35055 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-24 |
| Decision Date | 2021-03-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30680651492426 | K201095 | 000 |