The following data is part of a premarket notification filed by Guilin Hbm Sanitary Protections, Inc with the FDA for Medical Face Masks.
Device ID | K202627 |
510k Number | K202627 |
Device Name: | Medical Face Masks |
Classification | Mask, Surgical |
Applicant | Guilin HBM Sanitary Protections, Inc No.1-2, Shuijing East Road, Economic And Technological Development Area Guilin, CN 541805 |
Contact | Liu Xin |
Correspondent | Shelley Li Shanghai Landlink Medical Information Technology Co., Ltd. Room 703, 705, Baohua International Plaza, West Guangzhong Road 555, Jingan Shanghai, CN 200071 |
Product Code | FXX |
CFR Regulation Number | 878.4040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-09-11 |
Decision Date | 2021-02-03 |