The following data is part of a premarket notification filed by Ningbo Jingeao Electronics Inc. with the FDA for Surgical Mask.
| Device ID | K202746 |
| 510k Number | K202746 |
| Device Name: | Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | Ningbo Jingeao Electronics Inc. No.2 Jinyuan Road, Longshan Industrial Zone Cixi, CN 315311 |
| Contact | Yiyun Yu |
| 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 | 2020-09-18 |
| Decision Date | 2021-08-27 |