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 |