The following data is part of a premarket notification filed by Hebei Titans Hongsen Medical Technology Co., Ltd with the FDA for Disposable Medical Surgical Mask.
| Device ID | K212097 |
| 510k Number | K212097 |
| Device Name: | Disposable Medical Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | Hebei Titans Hongsen Medical Technology Co., LTD Eastern Industrial Concentration Zone, Nangong City Xingtai, CN 055750 |
| Contact | Chai Wu |
| 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 | 2021-07-06 |
| Decision Date | 2021-08-18 |