The following data is part of a premarket notification filed by Bain Medical Equipment (guangzhou) Co., Ltd with the FDA for Dora Tubing Sets For Hemodialysis.
| Device ID | K161582 |
| 510k Number | K161582 |
| Device Name: | DORA Tubing Sets For Hemodialysis |
| Classification | Set, Tubing, Blood, With And Without Anti-regurgitation Valve |
| Applicant | Bain Medical Equipment (Guangzhou) Co., Ltd No. 10 Juncheng Road Eastern Zone Of Guangzhou Economic & Technological Guangzhou, CN 510760 |
| Contact | Sophia Shao |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, CN 200120 |
| Product Code | FJK |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-08 |
| Decision Date | 2017-06-16 |
| Summary: | summary |