The following data is part of a premarket notification filed by Medwell Technology Ltd with the FDA for Medwell Technology Ltd Syringes, Various Sizes.
| Device ID | K212764 |
| 510k Number | K212764 |
| Device Name: | Medwell Technology Ltd Syringes, Various Sizes |
| Classification | Syringe, Piston |
| Applicant | Medwell Technology Ltd 8th Building, Pujing, Fumin Industry Zone, DaLang Town Dongguan City, CN 523770 |
| Contact | Andy Song |
| Correspondent | Jonathan Gilbert Medwell Technology Ltd 1641 Jeurissen Lane Chanhassen, MN 55317 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-31 |
| Decision Date | 2022-11-04 |