The following data is part of a premarket notification filed by Jiangsu Caina Medical Co., Ltd. with the FDA for Huber Needle Infusion Set, Safety Huber Needle Infusion Set.
| Device ID | K200463 |
| 510k Number | K200463 |
| Device Name: | Huber Needle Infusion Set, Safety Huber Needle Infusion Set |
| Classification | Non-coring (huber) Needle |
| Applicant | Jiangsu Caina Medical Co., Ltd. No.23, Huanxi Rd, Zhutang Town Jiangyin, CN 214415 |
| Contact | Jianwei Pan |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd. P.O.BOX 120-119 Shanghai, CN 200120 |
| Product Code | PTI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-25 |
| Decision Date | 2021-04-07 |