The following data is part of a premarket notification filed by Topwide Medical Products Manufacturer with the FDA for Topwide Surgical Face Mask.
Device ID | K210102 |
510k Number | K210102 |
Device Name: | Topwide Surgical Face Mask |
Classification | Mask, Surgical |
Applicant | Topwide Medical Products Manufacturer 19 Xianhong Road, Xin Li Ren Kou Xiantao, CN 433012 |
Contact | Shoucheng Zhang |
Correspondent | Jimmy Wu Lee And Xiao 2600 Mission Street, Suite 206 San Marino, CA 91108 |
Product Code | FXX |
CFR Regulation Number | 878.4040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-01-14 |
Decision Date | 2021-12-17 |