Niti-S Biliary Slim M Stent

Stents, Drains And Dilators For The Biliary Ducts

Taewoong Medical Co., Ltd

The following data is part of a premarket notification filed by Taewoong Medical Co., Ltd with the FDA for Niti-s Biliary Slim M Stent.

Pre-market Notification Details

Device IDK221071
510k NumberK221071
Device Name:Niti-S Biliary Slim M Stent
ClassificationStents, Drains And Dilators For The Biliary Ducts
Applicant Taewoong Medical Co., Ltd 14 Gojeong-ro, Wolgot-myeon Gimpo-si,  KR 10022
ContactJangsoo Lee
CorrespondentMatthew Krueger
Biologics Consulting Group, Inc. 1555 King Street, Suite 300 Alexandria,  VA  22314
Product CodeFGE  
CFR Regulation Number876.5010 [🔎]
DecisionSE - With Limitations (SESU)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-12
Decision Date2022-06-09

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