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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 K073667
Device Name NITI-S BILIARY STENT
Applicant
Taewoong Medical Co., Ltd.
5536 Trowbridge Dr.
Dunwoody,  GA  30338
Applicant Contact CATHRYN N CAMBRIA
Correspondent
Taewoong Medical Co., Ltd.
5536 Trowbridge Dr.
Dunwoody,  GA  30338
Correspondent Contact CATHRYN N CAMBRIA
Regulation Number876.5010
Classification Product Code
FGE  
Date Received12/26/2007
Decision Date 11/19/2008
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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