The following data is part of a premarket notification filed by Macheng Thimble Technology Investment Co., Ltd with the FDA for Surgical Face Mask.
| Device ID | K211631 |
| 510k Number | K211631 |
| Device Name: | Surgical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Macheng Thimble Technology Investment Co., Ltd Xiling 2nd Road, Douposhan Village, Macheng Economic Development Zone Huanggang, CN 438000 |
| Contact | Donghong Sheng |
| Correspondent | Ivy Wang Shanghai Sungo Management Consulting Company Limited 13th Floor, 1500# Central Avenue Shangghai, 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 | 2021-05-27 |
| Decision Date | 2021-08-18 |