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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stent, metallic, expandable, duodenal
510(k) Number K223067
Device Name Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent
Applicant
Taewoong Medical Co., Ltd.
14 Gojeong-ro, Wolgot-myeon
Gimpo-si,  KR 10022
Applicant Contact Yongjin Kim
Correspondent
MED Institute
1330 Win Hentschel Boulevard
Suite 100
West Lafayette,  IN  47906
Correspondent Contact Daniel J Dillon
Regulation Number878.3610
Classification Product Code
MUM  
Subsequent Product Code
MQR  
Date Received09/23/2022
Decision Date 06/14/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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