The following data is part of a premarket notification filed by Knh Surgical Face Mask with the FDA for Knh Surgical Face Mask.
| Device ID | K203528 |
| 510k Number | K203528 |
| Device Name: | KNH Surgical Face Mask |
| Classification | Mask, Surgical |
| Applicant | KNH Surgical Face Mask 1, 2, 4F, Of No.66-1, Sanji, Jiangjun Village, Jiangjun District Tainan, TW 72548 |
| Contact | Robert Y.L. Pan |
| Correspondent | Brian Wu KNH Enterprise Co., Ltd 1, 2, 4F., No.66-1, Sanji, Jiangjun Village Jiangjun District Tainan City, TW 725034 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-02 |
| Decision Date | 2022-11-16 |