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 |