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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
Applicant
Corpak Medsystems
100 Chaddick Dr.
Wheeling,  IL  60090
Applicant Contact STEPHANIE WASIELEWSKI
Correspondent
Corpak Medsystems
100 Chaddick Dr.
Wheeling,  IL  60090
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
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