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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 K221482
Device Name Esophageal TTS Stent
Applicant
Taewoong Medical Co., Ltd.
14 Gojeong-Ro, Wolgot-Myeon
Gimpo-Si,  KR 10022
Applicant Contact Jangsoo Lee
Correspondent
Biologics Consulting Group, Inc.
1555 King St.,
Suite 300
Alexandria,  VA  22314
Correspondent Contact Matthew Krueger
Regulation Number878.3610
Classification Product Code
ESW  
Date Received05/23/2022
Decision Date 06/22/2022
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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