The following data is part of a premarket notification filed by Unimax Medical Products Co., Ltd. with the FDA for Surgical Face Mask, Model Number-17.5x9.5cm Ear-loop.
| Device ID | K220749 |
| 510k Number | K220749 |
| Device Name: | Surgical Face Mask, Model Number-17.5X9.5CM EAR-LOOP |
| Classification | Mask, Surgical |
| Applicant | Unimax Medical Products Co., Ltd. No.1 Liansai Road, Changshangkou Town Xiantao, CN |
| Contact | Haibo Ning |
| Correspondent | Jarvis Wu 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 | 2022-03-14 |
| Decision Date | 2022-05-13 |