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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 K083786
Device Name CORFLO ANTI-IV ENTERAL FEEDING EXTENSION SET, MODELS 20-1006AIV-LB AND 20-1030AIV-LB
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 02/20/2009
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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