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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 K083776
Device Name CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1030AIV-LB-S
Original Applicant
CORPAK MEDSYSTEMS
100 chaddick dr.
wheeling,  IL  60090
Original Contact stephanie wasielewski
Regulation Number876.5980
Classification Product Code
FPD  
Date Received12/19/2008
Decision Date 03/05/2009
Decision substantially equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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