The following data is part of a premarket notification filed by Guangdong Horigen Mother & Baby Products Co., Ltd with the FDA for Single-use Medical Face Mask.
| Device ID | K201974 |
| 510k Number | K201974 |
| Device Name: | Single-use Medical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Guangdong Horigen Mother & Baby Products Co., Ltd Block A&B&C, NCBC Industrial Park, 6th Baolong Road, Longgang District Shantou, CN 515100 |
| Contact | Jun Deng |
| Correspondent | Olivia Meng Guangzhou Osmunda Medical Device Technical Service Co.,Ltd. 8-9th Floor, R&D Building, No.26 Qinglan Street Panyu District Guangzhou, CN 510006 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-15 |
| Decision Date | 2021-03-07 |