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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 K041648
Device Name NITI-S STENT & INTRODUCER, MODEL EOXXXX
Applicant
TAEWOONG MEDICAL CO., LTD
11874 SOUTH EVELYN CIRCLE
HOUSTON,  TX  77071
Applicant Contact JAMES HARVY KNAUSS
Correspondent
TAEWOONG MEDICAL CO., LTD
11874 SOUTH EVELYN CIRCLE
HOUSTON,  TX  77071
Correspondent Contact JAMES HARVY KNAUSS
Regulation Number878.3610
Classification Product Code
ESW  
Date Received06/17/2004
Decision Date 04/28/2005
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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