The following data is part of a premarket notification filed by Bain Medical Equipment (guangzhou) Co., Ltd. with the FDA for Surgical Masks.
| Device ID | K203524 |
| 510k Number | K203524 |
| Device Name: | Surgical Masks |
| Classification | Mask, Surgical |
| Applicant | Bain Medical Equipment (Guangzhou) Co., Ltd. No.10 Juncheng Road, Eastern Area, E&T Development District, Guangzhou, China Guangzhou, CN 510760 |
| Contact | Mu Fanzhen |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. Box. 120-119 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 | 2020-12-01 |
| Decision Date | 2021-02-25 |