The following data is part of a premarket notification filed by Hubei Yi-ya Protective Products Co., Ltd with the FDA for Surgical Face Mask.
| Device ID | K211899 |
| 510k Number | K211899 |
| Device Name: | Surgical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Hubei YI-YA PROTECTIVE PRODUCTS CO., LTD Miandong Road, Hefeng Village, Xiliuhe Town, Xiantao City, Xiantao, CN |
| Contact | Moody Shaw |
| Correspondent | Ivy Wang 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 | 2021-06-21 |
| Decision Date | 2021-10-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06974323931010 | K211899 | 000 |