Device Classification Name |
cannula, manipulator/injector, uterine
|
510(k) Number |
K172846 |
Device Name |
Uterine Manipulator |
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
|
|
Applicant Contact |
Liying Zhang |
Correspondent |
Mid-Link Consulting Co.,Ltd. |
P.O.Box 120-119 |
Shanghai,
CN
200120
|
|
Correspondent Contact |
Diana Hong |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 09/19/2017 |
Decision Date | 06/26/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|