The following data is part of a premarket notification filed by Jiangsu Caina Medical Co., Ltd with the FDA for Syringe With Safety Needle, Safety Needle.
| Device ID | K193526 |
| 510k Number | K193526 |
| Device Name: | Syringe With Safety Needle, Safety Needle |
| Classification | Syringe, Piston |
| 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 | FMF |
| Subsequent Product Code | FMI |
| Subsequent Product Code | MEG |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-19 |
| Decision Date | 2020-07-17 |