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 | K202139 |
| 510k Number | K202139 |
| 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 | 2020-07-31 |
| Decision Date | 2020-11-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06973163400007 | K202139 | 000 |
| 16973163400011 | K202139 | 000 |
| 06973163406184 | K202139 | 000 |
| 26973163407116 | K202139 | 000 |