K210767 is an FDA 510(k) clearance for the Surgical Masks, Model:FE-1. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Hunan Triplex Precision Medical Devices Co., Ltd. (Changsha, CN). The FDA issued a Cleared decision on June 10, 2021, 87 days after receiving the submission on March 15, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K210767 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 15, 2021 |
| Decision Date | June 10, 2021 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FXX - Mask, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |