Locking Device

Endoscope Channel Accessory

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 Locking Device.

Pre-market Notification Details

Device IDK202237
510k NumberK202237
Device Name:Locking Device
ClassificationEndoscope Channel Accessory
Applicant Hangzhou AGS MedTech Co., Ltd. Building 5, Building 6, No.597 Kangxin Road Yuhang District Hangzhou,  CN 311106
ContactYanping Fu
CorrespondentYanping Fu
Hangzhou AGS MedTech Co., Ltd. Building 5, Building 6, No.597 Kangxin Road Yuhang District Hangzhou,  CN 311106
Product CodeODC  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-07
Decision Date2020-12-23

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