The following data is part of a premarket notification filed by Luoyang Sunmed Devices Co., Ltd. with the FDA for Surgical Mask.
| Device ID | K222335 |
| 510k Number | K222335 |
| Device Name: | Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | Luoyang Sunmed Devices Co., Ltd. No. 8 Huaxia Road, Hi-Tech Zone, Luoyang Area Of China (Henan) Pilot Free Trade Zone Luoyang, CN 471003 |
| Contact | Tian Qian |
| Correspondent | Grace Liu Shenzhen Joyantech Consulting Co. Ltd 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, CN 518000 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-03 |
| Decision Date | 2022-10-11 |