The following data is part of a premarket notification filed by Jiangsu Jianyu Health Medical Co., Ltd. with the FDA for Jianyu Surgical Mask.
| Device ID | K201754 |
| 510k Number | K201754 |
| Device Name: | JianYu Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | Jiangsu JianYu Health Medical Co., Ltd. No. 88 Longxi Avenue, Zhulin Town, Jintan District Changzhou, CN 213241 |
| Contact | Andy Shu |
| Correspondent | Andy Shu Jiangsu JianYu Health Medical Co., Ltd. No. 88 Longxi Avenue, Zhulin Town, Jintan District Changzhou, CN 213241 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-29 |
| Decision Date | 2020-12-30 |