The following data is part of a premarket notification filed by Homtex, Inc. with the FDA for Sovereign America Surgical Mask, Model Number: 2000sm2, Sovereign America Surgical Mask, Model Number: 2000sm3.
| Device ID | K211066 |
| 510k Number | K211066 |
| Device Name: | Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask, Model Number: 2000SM3 |
| 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 | 2021-04-12 |
| Decision Date | 2021-08-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30680651492402 | K211066 | 000 |