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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 K123205
Device Name ESOPHAGEAL TTS STENT
Applicant
TAEWOONG MEDICAL CO., LTD
13417 QUIVAS ST
WESTMINSTER,  CO  80234
Applicant Contact Calley Herzog
Correspondent
TAEWOONG MEDICAL CO., LTD
13417 QUIVAS ST
WESTMINSTER,  CO  80234
Correspondent Contact Calley Herzog
Regulation Number878.3610
Classification Product Code
ESW  
Date Received10/12/2012
Decision Date 10/09/2013
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
Recalls CDRH Recalls
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