Ureterorenoscope System

Ureteroscope And Accessories, Flexible/rigid

Shanghai AnQing Medical Instrument Co., Ltd.

The following data is part of a premarket notification filed by Shanghai Anqing Medical Instrument Co., Ltd. with the FDA for Ureterorenoscope System.

Pre-market Notification Details

Device IDK201293
510k NumberK201293
Device Name:Ureterorenoscope System
ClassificationUreteroscope And Accessories, Flexible/rigid
Applicant Shanghai AnQing Medical Instrument Co., Ltd. 3rd & 4th Floor, No.2 Building, 366 Huiqing Road Zhangjiang High-Tech Park Shanghai,  CN 201201
ContactShuwen Fan
CorrespondentShuwen Fan
Shanghai AnQing Medical Instrument Co., Ltd. 3rd & 4th Floor, No.2 Building, 366 Huiqing Road Zhangjiang High-Tech Park Shanghai,  CN 201201
Product CodeFGB  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-14
Decision Date2020-07-24

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