510(k) K172151

Hysteroscopy System by Chongquin Jinshan Science & Technology (Group) Co., Ltd. — Product Code HGH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 2018
Date Received
July 17, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Suction, Uterine
Device Class
Class II
Regulation Number
884.5070
Review Panel
OB
Submission Type