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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 K250663
Device Name Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent
Applicant
Taewoong Medical Co., Ltd.
14, Gojeong-Ro
Wolgot-Myeon, Gimpo-Si
Gyeonggi-Do,  KR 10022
Applicant Contact Yongjin "Jeff" Kim
Correspondent
Biologics Consulting Group
100 Daingerfield Rd.
Suite 400
Alexandria,  VA  22314
Correspondent Contact Matthew Krueger
Regulation Number878.3610
Classification Product Code
MUM  
Subsequent Product Code
MQR  
Date Received03/05/2025
Decision Date 03/31/2025
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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