The following data is part of a premarket notification filed by Advcare Medical with the FDA for Advcare Vial Direct To Bag (vdb) Needle-free Admixture Devices.
| Device ID | K212525 |
| 510k Number | K212525 |
| Device Name: | Advcare Vial Direct To Bag (VDB) Needle-free Admixture Devices |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | Advcare Medical No. 36, Sinsing Street, Shulin District New Taipei, TW 23877 |
| Contact | Meng T. Tan |
| Correspondent | Meng T. Tan Advcare Medical No. 36, Sinsing Street, Shulin District New Taipei, TW 23877 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-11 |
| Decision Date | 2022-08-19 |