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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 K100365
Device Name FARRELL VALVE WITH CORFLO ANTI-IV CONNECTORS MODEL 20-4300AIV
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
KNT  
Date Received02/12/2010
Decision Date 05/20/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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