Esophageal Stent System

Prosthesis, Esophageal

Micro-Tech (Nanjing) Co.,Ltd.

The following data is part of a premarket notification filed by Micro-tech (nanjing) Co.,ltd. with the FDA for Esophageal Stent System.

Pre-market Notification Details

Device IDK172813
510k NumberK172813
Device Name:Esophageal Stent System
ClassificationProsthesis, Esophageal
Applicant Micro-Tech (Nanjing) Co.,Ltd. No.10 Gaoke Third Road Nanjing,  CN 210032
ContactBecky Li
CorrespondentBecky Li
Micro-Tech (Nanjing) Co.,Ltd. No.10 Gaoke Third Road Nanjing,  CN 210032
Product CodeESW  
CFR Regulation Number878.3610 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-18
Decision Date2018-05-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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