The following data is part of a premarket notification filed by Henan Huibo Medical Co.,ltd. with the FDA for Medical Surgical Mask.
| Device ID | K202842 |
| 510k Number | K202842 |
| Device Name: | Medical Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | Henan Huibo Medical Co.,Ltd. Weishi Road Central, Nanyang New Energy Economic And Technological Zone Nanyang, CN 473000 |
| Contact | Hui Lu |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM.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 | 2020-09-25 |
| Decision Date | 2021-11-26 |