The following data is part of a premarket notification filed by Bain Medical Equipment(guangzhou) Co., Ltd. with the FDA for Novaline Tubing Sets For Hemodialysis.
| Device ID | K201866 |
| 510k Number | K201866 |
| Device Name: | NovaLine 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 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 | FJK |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-07 |
| Decision Date | 2021-03-10 |