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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name tube, feeding
510(k) Number K091340
Device Name THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M00566320,M00566330, M00566340, M00566350
Applicant
BOSTON SCIENTIFIC CORP.
100 BOSTON SCIENTIFIC WAY
MARLBOROUGH,  MA  01752
Applicant Contact Marybeth Gamber
Correspondent
BOSTON SCIENTIFIC CORP.
100 BOSTON SCIENTIFIC WAY
MARLBOROUGH,  MA  01752
Correspondent Contact Marybeth Gamber
Regulation Number876.5980
Classification Product Code
FPD  
Subsequent Product Code
KNT  
Date Received05/06/2009
Decision Date 06/09/2009
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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