The following data is part of a premarket notification filed by Wanxinda (guangzhou) Technology Product Co., Ltd with the FDA for Surgical Face Mask.
| Device ID | K202548 |
| 510k Number | K202548 |
| Device Name: | Surgical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Wanxinda (Guangzhou) Technology Product Co., Ltd Ling Xi Road, Accessory Section 2, Automobile Zone, Huada District Guangzhou, CN 510800 |
| Contact | Zeng Xueping |
| Correspondent | Joyce No Last Name Provided Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, CN 518100 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-02 |
| Decision Date | 2021-03-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06945015300032 | K202548 | 000 |
| 06945015300018 | K202548 | 000 |