The following data is part of a premarket notification filed by Bain Medical Equipment (guangzhou)co., Ltd. with the FDA for Dora Disposable A.v. Fistula Needle Sets.
| Device ID | K213015 |
| 510k Number | K213015 |
| Device Name: | DORA Disposable A.V. Fistula Needle Sets |
| Classification | Needle, Fistula |
| Applicant | Bain Medical Equipment (Guangzhou)Co., Ltd. No.10, Juncheng Road, Eastern Area, Economic And Technological Development Guangzhou, CN 510760 |
| Contact | Zoe Zeng |
| Correspondent | Zoe Zeng Bain Medical Equipment (Guangzhou)Co., Ltd. No.10, Juncheng Road, Eastern Area, Economic And Technological Development Guangzhou, CN 510760 |
| Product Code | FIE |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-20 |
| Decision Date | 2022-04-08 |