The following data is part of a premarket notification filed by Ammex-weida (hubei) Health And Safety Products Co., Ltd with the FDA for Medical Face Mask.
| Device ID | K211062 |
| 510k Number | K211062 |
| Device Name: | Medical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Ammex-Weida (Hubei) Health And Safety Products Co., Ltd Southern Industrial Zone (Xinlirenkou), Xiantao, Hubei, China Xiantao, CN 433011 |
| Contact | Cai Mingqing |
| Correspondent | Cynthia Xiang Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, CN 200122 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-09 |
| Decision Date | 2021-06-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06973219621011 | K211062 | 000 |