FDA 510(k) Application Details - K172846

Device Classification Name	Cannula, Manipulator/Injector, Uterine   More FDA Info for this Device
510(K) Number	K172846
Device Name	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 101102 CN Other 510(k) Applications for this Company
Contact	Liying Zhang Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LKF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/19/2017
Decision Date	06/26/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review