The following data is part of a premarket notification filed by Yunyi (beijing) Medical Device Co., Ltd. with the FDA for Button Loop.
| Device ID | K202291 |
| 510k Number | K202291 |
| Device Name: | Button Loop |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Yunyi (Beijing) Medical Device Co., Ltd. Floor 1-4, Building 4, No. 9 Tianfu Street, Biomedical Base, Daxing District Beijing, CN 102600 |
| Contact | Xiaowei Liu |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd. P.O. BOX 120-119 Shanghai, CN 200120 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-12 |
| Decision Date | 2021-01-08 |