The following data is part of a premarket notification filed by Jiangsu Suyun Medical Materials Co., Ltd. with the FDA for Infusion Sets For Single Use.
| Device ID | K202437 |
| 510k Number | K202437 |
| Device Name: | Infusion Sets For Single Use |
| Classification | Set, Administration, Intravascular |
| Applicant | Jiangsu Suyun Medical Materials Co., Ltd. No.18 Jinaqiao Road, Dapu Industrial Park, Lianyungang Economic Development Zone Lianyungang, CN 222002 |
| Contact | Guangning Xu |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai, CN 200120 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-25 |
| Decision Date | 2022-03-25 |