The following data is part of a premarket notification filed by Shenzhen Jinko Industrial Co., Ltd with the FDA for Disposable Medical Face Mask-model Fm-04.
Device ID | K202513 |
510k Number | K202513 |
Device Name: | Disposable Medical Face Mask-Model FM-04 |
Classification | Mask, Surgical |
Applicant | Shenzhen Jinko Industrial Co., Ltd Building B2 101, Haocheng (Heping) Industrial Park, No. 66 Hexiu West Road Shenzhen, CN 518100 |
Contact | Wang Yinghui |
Correspondent | Joyce Yang 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 | 2020-08-31 |
Decision Date | 2021-04-09 |