HANAROSTENT FASTTM 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 Fasttm Biliary (nnn).

Pre-market Notification Details

Device IDK183396
510k NumberK183396
Device Name:HANAROSTENT FASTTM 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
CorrespondentBeryl St. Jeanne
Namsa 400 Highway 169 South, Suite 500 Minneapolis,  MN  55426
Product CodeFGE  
CFR Regulation Number876.5010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-07
Decision Date2019-02-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08806367082053 K183396 000
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08806367073341 K183396 000
08806367073358 K183396 000
08806367073365 K183396 000
08806367073372 K183396 000
08806367073389 K183396 000
08806367073396 K183396 000
08806367073693 K183396 000
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08806367073716 K183396 000
08806367073723 K183396 000
08806367073730 K183396 000
08806367073747 K183396 000
08806367082022 K183396 000
08806367082039 K183396 000
08806367082046 K183396 000
08806367073327 K183396 000

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