Hysteroscopy System

Cannula, Suction, Uterine

Chongquin Jinshan Science & Technology (Group) Co., Ltd.

The following data is part of a premarket notification filed by Chongquin Jinshan Science & Technology (group) Co., Ltd. with the FDA for Hysteroscopy System.

Pre-market Notification Details

Device IDK172151
510k NumberK172151
Device Name:Hysteroscopy System
ClassificationCannula, Suction, Uterine
Applicant Chongquin Jinshan Science & Technology (Group) Co., Ltd. Yubei District No. 18 Ningshang Avenue Jinshan International Industrial City Chongqing,  CN 400000
ContactQing Xu
CorrespondentQing Xu
Chongquin Jinshan Science & Technology (Group) Co., Ltd. Yubei District No. 18 Ningshang Avenue Jinshan International Industrial City Chongqing,  CN 400000
Product CodeHGH  
CFR Regulation Number884.5070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-07-17
Decision Date2018-04-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06946332802261 K172151 000
06946332802209 K172151 000
06946332802148 K172151 000
06946332802117 K172151 000

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