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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tubes, gastrointestinal (and accessories)
510(k) Number K072476
Device Name THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT
Applicant
Boston Scientific Corporation
100 BOSTON SCIENTIFIC WAY
MARLBOROUGH,  MA  01752
Applicant Contact VIRGINIA CARR
Correspondent
Boston Scientific Corporation
100 BOSTON SCIENTIFIC WAY
MARLBOROUGH,  MA  01752
Correspondent Contact VIRGINIA CARR
Regulation Number876.5980
Classification Product Code
KNT  
Date Received09/04/2007
Decision Date 12/14/2007
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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