The following data is part of a premarket notification filed by Huizhou Tianchang Industrial Co., Ltd with the FDA for Carewe Surgical Face Mask Models N001-aw, N002-aw, And N003-aw.
| Device ID | K203078 |
| 510k Number | K203078 |
| Device Name: | CAREWE Surgical Face Mask Models N001-AW, N002-AW, And N003-AW |
| Classification | Mask, Surgical |
| Applicant | HuiZhou TianChang Industrial Co., Ltd No.2 XingDe East Road, DongJiang Hi-Tech Industrial Park, ZhongKai Hi-Tech Industrial Park, Shuikou Town, Huicheng Dis Huizhou, CN 516005 |
| Contact | Johnny Chan |
| Correspondent | Viky Verna Mhetra LLC 848 Brickell Ave. PH 5 Miami, FL 33131 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-13 |
| Decision Date | 2022-08-19 |