The following data is part of a premarket notification filed by Gcmedica Enterprise Ltd., (wuxi) with the FDA for Decanting Device.
| Device ID | K182819 |
| 510k Number | K182819 |
| Device Name: | Decanting Device |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | Gcmedica Enterprise Ltd., (WUXI) Loujin Industrial Park, Shuofang Wuxi, CN 214143 |
| Contact | Mona Zhang |
| Correspondent | Ethan Liu Shanghai Thinkwell Consulting Co., Ltd Xinling Road, 211/6F Shanghai, CN 201100 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-04 |
| Decision Date | 2019-12-02 |