The following data is part of a premarket notification filed by Hubei Wanli Protective Products Co., Ltd. with the FDA for Disposable Medical Mask.
| Device ID | K210150 |
| 510k Number | K210150 |
| Device Name: | Disposable Medical Mask |
| Classification | Mask, Surgical |
| Applicant | Hubei Wanli Protective Products Co., Ltd. Yuanshi, Ganhe Xiantao, CN 433000 |
| Contact | Andy Wen |
| Correspondent | Eva Li Shanghai Sungo Management Consulting Company Limited Room 1309, Dongfang Building, 1500#Century Ave Shanghai, CN 200122 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-21 |
| Decision Date | 2021-06-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06973888820005 | K210150 | 000 |