HANAROSTENT Benefit Biliary (NNN)

Stents, Drains And Dilators For The Biliary Ducts

M.I.Tech Co., Ltd.

The following data is part of a premarket notification filed by M.i.tech Co., Ltd. with the FDA for Hanarostent Benefit Biliary (nnn).

Pre-market Notification Details

Device IDK202973
510k NumberK202973
Device Name:HANAROSTENT Benefit Biliary (NNN)
ClassificationStents, Drains And Dilators For The Biliary Ducts
Applicant M.I.Tech Co., Ltd. 174, Habuk 2-gil, Jinwi-myeon Pyeongtaek-si,  KR 17706
ContactInae Kim
CorrespondentKelly Kucharczyk
Namsa 400 Highway 169 South, Suite 500 Minneapolis,  MN  55426
Product CodeFGE  
CFR Regulation Number876.5010 [🔎]
DecisionSe - With Limitations (SESU)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-30
Decision Date2021-05-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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