The following data is part of a premarket notification filed by Fujian Meo Medical Technology Limited with the FDA for Meo Med Disposable Medical Face Mask.
| Device ID | K210870 |
| 510k Number | K210870 |
| Device Name: | MEO Med Disposable Medical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Fujian MEO Medical Technology Limited Floor 4th, No. 1 Production Building, No. 36 Guabao Road, Dongqiao Business Development Zone Ningde, CN 352100 |
| Contact | Zhuang Yan |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738, Shangcheng Rd., Pudong Shanghai, CN 200120 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-24 |
| Decision Date | 2021-07-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06973114620300 | K210870 | 000 |