The following data is part of a premarket notification filed by Jiangsu Suyun Medical Material Co., Ltd. with the FDA for Sterile Syringe For Single Use.
| Device ID | K210914 |
| 510k Number | K210914 |
| Device Name: | Sterile Syringe For Single Use |
| Classification | Syringe, Piston |
| Applicant | Jiangsu Suyun Medical Material Co., Ltd. No.18 Jinqiao Road, Dapu Industrial Park Lianyungang, CN 222000 |
| Contact | Guangning Xu |
| Correspondent | Diana Hong Mid-Link Consulting Co.,Ltd P.O.BOX 120-119 Shanghai, CN 200120 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-29 |
| Decision Date | 2021-12-17 |