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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name cannula, manipulator/injector, uterine
510(k) Number K172846
Device Name Uterine Manipulator
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
Mid-Link Consulting Co.,Ltd.
P.O.Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number884.4530
Classification Product Code
Date Received09/19/2017
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