Disposable Stone Extraction Basket

Dislodger, Stone, Biliary

Hangzhou AGS MedTech Co., Ltd.

The following data is part of a premarket notification filed by Hangzhou Ags Medtech Co., Ltd. with the FDA for Disposable Stone Extraction Basket.

Pre-market Notification Details

Device IDK201509
510k NumberK201509
Device Name:Disposable Stone Extraction Basket
ClassificationDislodger, Stone, Biliary
Applicant Hangzhou AGS MedTech Co., Ltd. Building 5, Building 6, No.597 Kangxin Road Yuhang District Hangzhou,  CN 311106
ContactChunqi Han
CorrespondentChunqi Han
Hangzhou AGS MedTech Co., Ltd. Building 5, Building 6, No.597 Kangxin Road Yuhang District Hangzhou,  CN 311106
Product CodeLQR  
CFR Regulation Number876.5010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-05
Decision Date2020-12-16

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