The following data is part of a premarket notification filed by Xiantao Zhongyi Safety & Protection Products Co., Ltd with the FDA for Disposable Surgical Face Mask.
Device ID | K203685 |
510k Number | K203685 |
Device Name: | Disposable Surgical Face Mask |
Classification | Mask, Surgical |
Applicant | Xiantao Zhongyi Safety & Protection Products Co., Ltd No.101, Xianyuan Road Xiantao, CN 433000 |
Contact | Yang Xi |
Correspondent | Mandy Wu Shanghai Sungo Management Consulting Company Limited 13th Floor, 1500# Central Avenue Shanghai, CN 200122 |
Product Code | FXX |
CFR Regulation Number | 878.4040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-12-17 |
Decision Date | 2021-03-26 |