The following data is part of a premarket notification filed by Yunyi (beijing) Medical Device Co., Ltd with the FDA for High Strength Suture.
| Device ID | K192637 |
| 510k Number | K192637 |
| Device Name: | High Strength Suture |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| 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 | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-24 |
| Decision Date | 2020-03-02 |