The following data is part of a premarket notification filed by Guangdong Kingfa Sci.&tech.co., Ltd. with the FDA for Medical Protective Mask.
| Device ID | K202107 |
| 510k Number | K202107 |
| Device Name: | Medical Protective Mask |
| Classification | Mask, Surgical |
| Applicant | Guangdong Kingfa Sci.&Tech.Co., Ltd. 28 Delong Avenue, Shijiao Town, Qingcheng District Qingyuan, CN 511500 |
| Contact | Yu Xiaoge |
| Correspondent | Cassie Lee Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road Huangpu District Guangzhou, CN 510700 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-29 |
| Decision Date | 2021-01-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 26973163400100 | K202107 | 000 |
| 06973163404197 | K202107 | 000 |