The following data is part of a premarket notification filed by Anrei Medical (hangzhou) Co., Ltd. with the FDA for Single Use Injection Needle.
| Device ID | K210917 |
| 510k Number | K210917 |
| Device Name: | Single Use Injection Needle |
| Classification | Endoscopic Injection Needle, Gastroenterology-urology |
| Applicant | Anrei Medical (Hangzhou) Co., Ltd. No.3 Ave.8, HEDA Hangzhou, CN 310018 |
| Contact | Huibing Yang |
| Correspondent | Huibing Yang Anrei Medical (Hangzhou) Co., Ltd. No.3 Ave.8, HEDA Hangzhou, CN 310018 |
| Product Code | FBK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-29 |
| Decision Date | 2021-05-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06926839809161 | K210917 | 000 |
| 06926839809154 | K210917 | 000 |
| 06926839809130 | K210917 | 000 |
| 06926839809147 | K210917 | 000 |