The following data is part of a premarket notification filed by Jiangsu Medpure Biological Technology Co., Ltd. with the FDA for Surgical Mask.
| Device ID | K202640 |
| 510k Number | K202640 |
| Device Name: | Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | Jiangsu Medpure Biological Technology Co., Ltd. No. 1 Beiyang Road, Hexi Village, Zouqu Town Changzhou, CN 213144 |
| Contact | Jianwen Fei |
| 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 | 2020-09-11 |
| Decision Date | 2021-01-22 |