The following data is part of a premarket notification filed by Heilongjiang Yinjia Medical Equipment Co., Ltd. with the FDA for Disposable Surgical Mask.
| Device ID | K212944 |
| 510k Number | K212944 |
| Device Name: | Disposable Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | Heilongjiang Yinjia Medical Equipment Co., Ltd. F3-4, Plant 6, No.10, Hanan 12th Road, Nangang District Harbin, CN 150000 |
| Contact | Zhu Hongwei |
| Correspondent | Doris Dong Shanghai CV Technology Co., Ltd. Room 903, No.19 Dongbao Road, Songjiang Area Shanghai, CN 201613 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-13 |
| Decision Date | 2021-12-15 |