K200923 is an FDA 510(k) clearance for the Single-use Surgical Mask. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Byd Precision Manufacturer Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on August 26, 2020, 141 days after receiving the submission on April 7, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K200923 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 07, 2020 |
| Decision Date | August 26, 2020 |
| Days to Decision | 141 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 |