The following data is part of a premarket notification filed by Biobase Scientific (shandong) Co., Ltd. with the FDA for Disposable Face Mask.
| Device ID | K210815 |
| 510k Number | K210815 |
| Device Name: | Disposable Face Mask |
| Classification | Mask, Surgical |
| Applicant | Biobase Scientific (Shandong) Co., Ltd. No.1777 Dazheng Road, High-Tech District, Jinan City, Shandong Province, China Jinan, CN 250000 |
| Contact | Qingxiang Hou |
| 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 | 2021-03-18 |
| Decision Date | 2021-05-13 |