The following data is part of a premarket notification filed by Guangdong Jia Mei Biological Technology Co.ltd with the FDA for Medical Surgical Mask (model: Jm92, Jm92b).
| Device ID | K220187 |
| 510k Number | K220187 |
| Device Name: | Medical Surgical Mask (Model: JM92, JM92B) |
| Classification | Mask, Surgical |
| Applicant | Guangdong Jia Mei Biological Technology Co.Ltd 3/F, Block 1, No.356 Qinglan Road, Jianghai Jiangmen, CN 529040 |
| Contact | Jiali Chen |
| Correspondent | Cassie Lee Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District Guangzhou, CN |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-24 |
| Decision Date | 2022-03-25 |