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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 K223626
Device Name Niti-S Biliary Speed D Stent
Applicant
Taewoong Medical Co., Ltd
14 Gojeong-ro, Wolgot-myeon
Gimpo-si,  KR 10022
Applicant Contact Jangsoo Lee
Correspondent
Biologics Consulting Group, Inc.
100 Daingerfield Road, Suite 400
Alexandria,  VA  23314
Correspondent Contact Matthew Krueger
Regulation Number876.5010
Classification Product Code
FGE  
Date Received12/05/2022
Decision Date 05/26/2023
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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