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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stent, Colonic, Metallic, Expandable
510(k) Number K180180
Device Name HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (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 Carol Buchert
Regulation Number878.3610
Classification Product Code
MQR  
Subsequent Product Code
MUM  
Date Received01/23/2018
Decision Date 11/02/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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