The following data is part of a premarket notification filed by Hubei Kimsoul Industrial Co., Ltd with the FDA for Surgical Face Mask (non-sterile).
Device ID | K212398 |
510k Number | K212398 |
Device Name: | Surgical Face Mask (Non-sterile) |
Classification | Mask, Surgical |
Applicant | Hubei Kimsoul Industrial Co., Ltd NO. 1, Industrial Zone, Guohe Town Xiantao, CN 433013 |
Contact | Faming Zhang |
Correspondent | Grace Liu Shenzhen Joyantech Consulting Co. Ltd 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, CN 518000 |
Product Code | FXX |
CFR Regulation Number | 878.4040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-08-02 |
Decision Date | 2021-12-15 |