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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 K093537
Device Name HANAROSTENT ESOPHAGUS (CCC)
Applicant
M.I.Tech Co., Ltd.
49 Candle Wood Way
Buena Park,  CA  90621
Applicant Contact BRANDON CHOI
Correspondent
M.I.Tech Co., Ltd.
49 Candle Wood Way
Buena Park,  CA  90621
Correspondent Contact BRANDON CHOI
Regulation Number878.3610
Classification Product Code
ESW  
Date Received11/16/2009
Decision Date 06/04/2010
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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