The following data is part of a premarket notification filed by Guangdong Bida Medical Technology Co., Ltd. with the FDA for Disposable Surgical Face Mask.
| Device ID | K202387 |
| 510k Number | K202387 |
| Device Name: | Disposable Surgical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Guangdong Bida Medical Technology Co., Ltd. No.2, Xingfeng Rd, Shangsha Zhenxing District Chang'an Town, Dongguan City Dongguan, CN 523843 |
| Contact | Zhang Rong |
| Correspondent | Cassie Lee Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road Huangpu District, Guang Guangzhou, CN 510700 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-21 |
| Decision Date | 2021-04-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16970730050211 | K202387 | 000 |