The following data is part of a premarket notification filed by Beijing Hangtian Kadi Technology R&d Institute with the FDA for Uterine Manipulator.
| Device ID | K172846 |
| 510k Number | K172846 |
| Device Name: | Uterine Manipulator |
| Classification | Cannula, Manipulator/injector, Uterine |
| Applicant | Beijing HangTian KaDi Technology R&D Institute Room301-11, Third Floor, Building No.13, No.15 Jing Sheng Nan Er Street Beijing, CN 101102 |
| Contact | Liying Zhang |
| Correspondent | Diana Hong Mid-Link Consulting Co.,Ltd. P.O.Box 120-119 Shanghai, CN 200120 |
| Product Code | LKF |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-19 |
| Decision Date | 2018-06-26 |
| Summary: | summary |