The following data is part of a premarket notification filed by Zhongshan Saifute Labor Protective Articles Co., Ltd with the FDA for Surgical Face Mask.
Device ID | K212059 |
510k Number | K212059 |
Device Name: | Surgical Face Mask |
Classification | Mask, Surgical |
Applicant | Zhongshan Saifute Labor Protective Articles CO., LTD No.7, Xihuan 4th Road, Southern District Zhongshan, CN 528400 |
Contact | Qionghua Ke |
Correspondent | Qionghua Ke Zhongshan Saifute Labor Protective Articles CO., LTD No.7, Xihuan 4th Road, Southern District Zhongshan, CN 528400 |
Product Code | FXX |
CFR Regulation Number | 878.4040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-07-01 |
Decision Date | 2021-12-17 |