The following data is part of a premarket notification filed by Zhejiang Kangkang Medical-devices Co., Ltd. with the FDA for Sterile Syringe For Single Use With/without Needle.
| Device ID | K210227 |
| 510k Number | K210227 |
| Device Name: | Sterile Syringe For Single Use With/without Needle |
| Classification | Syringe, Piston |
| Applicant | Zhejiang Kangkang Medical-Devices CO., Ltd. Longwang Industrial District, Chumen Town Yuhuan, CN 317605 |
| Contact | Chun Guo |
| Correspondent | Chun Guo Zhejiang Kangkang Medical-Devices CO., Ltd. Longwang Industrial District, Chumen Town Yuhuan, CN 317605 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-28 |
| Decision Date | 2021-09-10 |