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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stents, drains and dilators for the biliary ducts
510(k) Number K202973
Device Name HANAROSTENT Benefit Biliary (NNN)
Applicant
M.I.Tech Co., Ltd.
174, Habuk 2-gil, Jinwi-myeon
Pyeongtaek-si,  KR 17706
Applicant Contact Inae Kim
Correspondent
Namsa
400 Highway 169 South, Suite 500
Minneapolis,  MN  55426
Correspondent Contact Kelly Kucharczyk
Regulation Number876.5010
Classification Product Code
FGE  
Date Received09/30/2020
Decision Date 05/11/2021
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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