The following data is part of a premarket notification filed by Jiangsu Caina Medical Co., Ltd. with the FDA for Pump Alignment Syringe.
| Device ID | K220184 |
| 510k Number | K220184 |
| Device Name: | Pump Alignment Syringe |
| Classification | Syringe, Piston |
| Applicant | Jiangsu Caina Medical Co., Ltd. No.23, Huanxi Road, Zhutang Town Jiangyin, CN 214415 |
| Contact | Jianwei Pan |
| Correspondent | Jianwei Pan Jiangsu Caina Medical Co., Ltd. No.23, Huanxi Road, Zhutang Town Jiangyin, CN 214415 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-24 |
| Decision Date | 2022-07-21 |