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 | K163025 |
| 510k Number | K163025 |
| Device Name: | DORA Disposable A.V. Fistula Needle Sets |
| Classification | Needle, Fistula |
| Applicant | Bain Medical Equipment (Guangzhou) Co., Ltd. No.10 Juncheng Road Eastern Zone Of Guangzhou E&T Development District Guangzhou, CN 510760 |
| Contact | Sophia Shao |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O.Box 120-119 Shanghai, CN 200120 |
| Product Code | FIE |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-31 |
| Decision Date | 2017-07-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 26948082700679 | K163025 | 000 |
| 26948082700693 | K163025 | 000 |
| 26948082700655 | K163025 | 000 |
| 26948082700631 | K163025 | 000 |
| 26948082700617 | K163025 | 000 |
| 26948082700594 | K163025 | 000 |