K211751 is an FDA 510(k) clearance for the WELLTRUST WT-III Mask with Flat Earloop. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Lonestar Meadows, LLC (Houston, US). The FDA issued a Cleared decision on September 17, 2021, 102 days after receiving the submission on June 7, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K211751 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 07, 2021 |
| Decision Date | September 17, 2021 |
| Days to Decision | 102 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FXX - Mask, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |