The following data is part of a premarket notification filed by Weihai Dishang Medical Technology Co., Ltd with the FDA for Disposable Medical Surgical Mask.
| Device ID | K210348 |
| 510k Number | K210348 |
| Device Name: | Disposable Medical Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | Weihai Dishang Medical Technology Co., Ltd Room 406-409, Block C, No.213 Torch Road, Torch High-Tech Industrial Development Zone Weihai, CN 264209 |
| Contact | Ricky Xia |
| Correspondent | Ricky Xia Weihai Dishang Medical Technology Co., Ltd Room 406-409, Block C, No.213 Torch Road, Torch High-Tech Industrial Development Zone Weihai, CN 264209 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-08 |
| Decision Date | 2021-10-24 |