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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 K183616
Device Name HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx 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 Beryl St. Jeanne
Regulation Number878.3610
Classification Product Code
MQR  
Subsequent Product Code
MUM  
Date Received12/26/2018
Decision Date 01/10/2019
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
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