The following data is part of a premarket notification filed by Guangdong Kingfa Sci.&tech.co.,ltd. with the FDA for Medical Surgical Mask.
| Device ID | K201622 |
| 510k Number | K201622 |
| Device Name: | Medical Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | Guangdong KINGFA Sci.&Tech.Co.,Ltd. 28 Delong Avenue, Shijiao Town, Qingcheng District, Qingyuan City, Guangdong 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 | 2020-06-15 |
| Decision Date | 2020-11-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06973163400021 | K201622 | 000 |
| 16973163400066 | K201622 | 000 |