The following data is part of a premarket notification filed by Hunan Heng Chang Pharmaceutical Co., Ltd. with the FDA for Protective Face Mask For Medical Use.
| Device ID | K202358 |
| 510k Number | K202358 |
| Device Name: | Protective Face Mask For Medical Use |
| Classification | Respirator, Surgical |
| Applicant | Hunan Heng Chang Pharmaceutical Co., Ltd. Floor 2,3, 102 Of Building 16, Standard Plant Of Shanhe Pharmaceutical And Health Changsha, CN 410000 |
| Contact | Tao Jingfeng |
| Correspondent | Shelley Li Shanghai Landlink Medical Information Technology Co., Ltd. Room 703, 705, Baohua International Plaza, West Guangzhong Road 555, Jingan Shanghai, CN 200071 |
| Product Code | MSH |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-19 |
| Decision Date | 2021-01-29 |