The following data is part of a premarket notification filed by Jiangsu Vedkang Medical Science And Technology Co.,ltd with the FDA for Injection Needle.
| Device ID | K213914 |
| 510k Number | K213914 |
| Device Name: | Injection Needle |
| Classification | Endoscopic Injection Needle, Gastroenterology-urology |
| Applicant | Jiangsu Vedkang Medical Science And Technology Co.,Ltd No. 52, Guoxiang Road, Wujin Economic Development Zone Changzhou, CN 213149 |
| Contact | Ting Tang |
| Correspondent | Diana Hong Mid-Link Consulting Co.,Ltd. P.O.BOX 120-119 Shanghai, CN 200120 |
| Product Code | FBK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-15 |
| Decision Date | 2022-07-29 |