The following data is part of a premarket notification filed by Jiangxi Hongda Medical Equipment Group Ltd. with the FDA for Sterile Single-use Infusion Set.
| Device ID | K163160 |
| 510k Number | K163160 |
| Device Name: | Sterile Single-use Infusion Set |
| Classification | Set, Administration, Intravascular |
| Applicant | JiangXi HongDa Medical Equipment Group Ltd. No. 39 South Shengli Road, Jinxian County Nanchang, CN 331700 |
| Contact | Xiaohua Yang |
| Correspondent | Diana Hong Mid-Link Consulting Co.,Ltd P.O.BOX 120-119 Shanghai, CN 200120 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-10 |
| Decision Date | 2017-04-20 |
| Summary: | summary |