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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 K080782
Device Name NITI-S ESOPHAGEAL 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 Number878.3610
Classification Product Code
ESW  
Date Received03/19/2008
Decision Date 01/30/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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