The following data is part of a premarket notification filed by Zhejiang Gongdong Medical Technology Co., Ltd. with the FDA for Disposable Urine Collection Tube.
| Device ID | K220739 |
| 510k Number | K220739 |
| Device Name: | Disposable Urine Collection Tube |
| Classification | Culture Media, Non-propagating Transport |
| Applicant | Zhejiang Gongdong Medical Technology Co., Ltd. No. 10 Beiyuan Ave., Huangyan Taizhou, CN 318020 |
| Contact | Handson Wei |
| Correspondent | Evan Hu Shanghai Mind-link Consulting Co., Ltd. 1399 Jiangyue Road, Minhang Shanghai, CN 201114 |
| Product Code | JSM |
| CFR Regulation Number | 866.2390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-14 |
| Decision Date | 2022-11-17 |