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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
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