The following data is part of a premarket notification filed by Chison Medical Technologies Co., Ltd. with the FDA for M1 Surgical Face Mask.
| Device ID | K202457 |
| 510k Number | K202457 |
| Device Name: | M1 Surgical Face Mask |
| Classification | Mask, Surgical |
| Applicant | CHISON Medical Technologies Co., Ltd. No.228, Changjiang East Road, Block 51 And 53, Phase 5, Shuofang Industrial Park, Xinwu District Wuxi, CN 214142 |
| Contact | Qifei Liu |
| Correspondent | Qifei Liu CHISON Medical Technologies Co., Ltd. No.228, Changjiang East Road, Block 51 And 53, Phase 5, Shuofang Industrial Park, Xinwu District Wuxi, CN 214142 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-27 |
| Decision Date | 2021-04-29 |