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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Suction, Uterine
510(k) Number K172151
Device Name Hysteroscopy System
Applicant
Chongquin Jinshan Science & Technology (Group) Co., Ltd.
Yubei District #18 Ningshang Ave.
Jinshan International Industrial City
Chongqing,  CN 400000
Applicant Contact Qing Xu
Correspondent
Chongquin Jinshan Science & Technology (Group) Co., Ltd.
Yubei District #18 Ningshang Ave.
Jinshan International Industrial City
Chongqing,  CN 400000
Correspondent Contact Qing Xu
Regulation Number884.5070
Classification Product Code
HGH  
Date Received07/17/2017
Decision Date 04/09/2018
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
Predetermined Change
Control Plan Authorized		 No
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