The following data is part of a premarket notification filed by Zhejiang Senhong Medical&instrument Co., Ltd. with the FDA for Disposable Medical Face Mask.
| Device ID | K202676 |
| 510k Number | K202676 |
| Device Name: | Disposable Medical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Zhejiang Senhong Medical&Instrument Co., Ltd. Floor 1-2, Building 2, No 889 North Huancheng Rd, Fu'xi Subdistrict, Deqing County Huzhou, CN 313200 |
| Contact | Eric Jian |
| 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 | 2020-09-15 |
| Decision Date | 2021-11-05 |