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 |