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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Esophageal
510(k) Number K213251
Device Name HANAROSTENT Esophagus Asymmetric (CCC)
Applicant
M.I. Tech Co., Ltd.
174 Habuk 2-Gil, Jinwi-Myeon
Pyeongtaek-Si,  KR 17706
Applicant Contact Sunyoung Jo
Correspondent
NAMSA
00 Highway 169 S., Suite 500
Minneapolis,  MN  55426
Correspondent Contact Heidi Busz
Regulation Number878.3610
Classification Product Code
ESW  
Date Received09/30/2021
Decision Date 11/18/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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