The following data is part of a premarket notification filed by Jiangmen Sure&me Medical Product Co., Ltd with the FDA for Medical Surgical Mask-model Mp002-5, Mp002-6.
| Device ID | K202577 |
| 510k Number | K202577 |
| Device Name: | Medical Surgical Mask-Model MP002-5, MP002-6 |
| Classification | Mask, Surgical |
| Applicant | Jiangmen Sure&Me Medical Product CO., LTD Jingshuiwan, Chakeng Village Committee, Huicheng Town, Xinhui District Jiangmen, CN 529000 |
| Contact | Liang Meixia |
| 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 | 2020-09-08 |
| Decision Date | 2021-01-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 26973069130019 | K202577 | 000 |
| 26973069130002 | K202577 | 000 |