The following data is part of a premarket notification filed by Suzhou Bolisi Medical Technology Co., Ltd with the FDA for Disposable Medical Face Mask.
| Device ID | K210244 |
| 510k Number | K210244 |
| Device Name: | Disposable Medical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Suzhou Bolisi Medical Technology Co., Ltd Baijiaqiao Industrial Community, Yangshe Town Zhangjiagang, CN 215000 |
| Contact | Hong Xu |
| Correspondent | Ryan Li Shanghai Mind-link Business Consulting Co., Ltd. Room A08, Floor 14th, No 699, Jiaozhou Road, Jingan District Shanghai, CN 200040 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-29 |
| Decision Date | 2021-07-12 |