The following data is part of a premarket notification filed by Byd Precision Manufacturer Co.ltd. with the FDA for Single-use Surgical Mask.
| Device ID | K200923 |
| 510k Number | K200923 |
| Device Name: | Single-use Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | BYD Precision Manufacturer Co.Ltd. No.3001 Baohe Road, Baolong Industrial Area, Longgang Shenzhen, CN 518116 |
| Contact | Yubo Guan |
| Correspondent | Annie Zhang Nova Clinical Solutions, Inc. 6792 Solterra Vista Pkwy San Diego, CA 92130 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-07 |
| Decision Date | 2020-08-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850022724169 | K200923 | 000 |
| 00850022724176 | K200923 | 000 |
| 00850022724190 | K200923 | 000 |
| 00850022724183 | K200923 | 000 |