The following data is part of a premarket notification filed by Qinhuangdao Taizhi Medical Technology Co., Ltd. with the FDA for Disposable Surgical Mask (non Sterile).
| Device ID | K211451 |
| 510k Number | K211451 |
| Device Name: | Disposable Surgical Mask (non Sterile) |
| Classification | Mask, Surgical |
| Applicant | Qinhuangdao Taizhi Medical Technology Co., Ltd. No.5, Small And Medium Enterprises Incubator Base, East Circular Economy Park, Haigang District Qinhuangdao, CN 066000 |
| Contact | Fan Xifan |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No.738, Shangcheng Rd., Pudong Shanghai, CN 200120 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-10 |
| Decision Date | 2021-08-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06973274100520 | K211451 | 000 |