The following data is part of a premarket notification filed by Shandong T&f Nonwoven Co., Ltd with the FDA for Medical Surgical Masks-non Sterile.
| Device ID | K202594 |
| 510k Number | K202594 |
| Device Name: | Medical Surgical Masks-Non Sterile |
| Classification | Mask, Surgical |
| Applicant | Shandong T&F Nonwoven Co., LTD South Of Shuangyong Road, Chengyang District Qingdao, CN 266100 |
| Contact | Minsheng Zhao |
| Correspondent | Ray Wang Beijing Believe-Med Technology Service Co., Ltd. Rm. 912, Building #15, XiYueHui, No. 5, YiHe North Rd., FangShan District Beijing, CN 102401 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-08 |
| Decision Date | 2021-01-06 |