The following data is part of a premarket notification filed by Zhejiang Kangkang Medical-devices Co., Ltd. with the FDA for Sterile Safety Hypodermic Needles For Single Use.
| Device ID | K213535 |
| 510k Number | K213535 |
| Device Name: | Sterile Safety Hypodermic Needles For Single Use |
| Classification | Needle, Hypodermic, Single Lumen |
| 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 | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-05 |
| Decision Date | 2022-05-13 |