The following data is part of a premarket notification filed by Ningbo Maxcon Medical Technology Co., Ltd. with the FDA for Maxcon Two Gallon Chemotherapy Container.
| Device ID | K180983 |
| 510k Number | K180983 |
| Device Name: | Maxcon Two Gallon Chemotherapy Container |
| Classification | Container, Sharps |
| Applicant | Ningbo Maxcon Medical Technology Co., Ltd. No.30 Dongbei Road/No.228 Dong Xin Road, Dong Qiao Town Ningbo, CN 315157 |
| Contact | Yang Song |
| Correspondent | Yang Song Ningbo Maxcon Medical Technology Co., Ltd. No.30 Dongbei Road/No.228 Dong Xin Road, Dong Qiao Town Ningbo, CN 315157 |
| Product Code | MMK |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-13 |
| Decision Date | 2019-01-03 |
| Summary: | summary |