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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stents, Drains And Dilators For The Biliary Ducts
510(k) Number K111149
Device Name HANAROSTENT BILIARY (NNN)
Applicant
M.I.Tech Co., Ltd.
1733 Canton Ln.
Marietta,  GA  30062
Applicant Contact PAUL SUMNER
Correspondent
M.I.Tech Co., Ltd.
1733 Canton Ln.
Marietta,  GA  30062
Correspondent Contact PAUL SUMNER
Regulation Number876.5010
Classification Product Code
FGE  
Date Received04/25/2011
Decision Date 12/30/2011
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
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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