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 |