The following data is part of a premarket notification filed by Ningbo Maxcon Medical Technology Co., Ltd. with the FDA for Maxcon Sharps Container.
| Device ID | K180984 |
| 510k Number | K180984 |
| Device Name: | Maxcon Sharps 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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970623201228 | K180984 | 000 |
| 06970623201419 | K180984 | 000 |
| 00369771003659 | K180984 | 000 |
| 16970623200099 | K180984 | 000 |
| 06970623200054 | K180984 | 000 |
| 10850014448384 | K180984 | 000 |
| 10850014448377 | K180984 | 000 |
| 10850014448360 | K180984 | 000 |
| 10850014448353 | K180984 | 000 |
| 10856471007263 | K180984 | 000 |
| 10856471007287 | K180984 | 000 |
| 06970623203529 | K180984 | 000 |
| 06970623200023 | K180984 | 000 |
| 06970623200016 | K180984 | 000 |
| 06970623200009 | K180984 | 000 |
| 06970623201426 | K180984 | 000 |
| 06970623200214 | K180984 | 000 |
| 06970623200092 | K180984 | 000 |
| 10856471007300 | K180984 | 000 |
| 10850014448346 | K180984 | 000 |