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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Tracheal, Expandable
510(k) Number K201342
Device Name HANAROSTENT Trachea/Bronchium (CCC)
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 S Suite 500
Minneapolis,  MN  55426
Correspondent Contact Beryl St. Jeanne
Regulation Number878.3720
Classification Product Code
JCT  
Date Received05/20/2020
Decision Date 12/31/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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