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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gastrointestinal Tubes With Enteral Specific Connectors
510(k) Number K142012
Device Name FARRELL VALVE SYSTEM WITH EQUILIBRIUM TECHNOLOGY AND ENFIT ENTERAL CONNECTORS
Applicant
Corpak Medsystems
1001 Asbury Dr.
Buffalo Grove,  IL  60089
Applicant Contact STEPHANIE WASIELEWKI
Correspondent
Corpak Medsystems
1001 Asbury Dr.
Buffalo Grove,  IL  60089
Correspondent Contact STEPHANIE WASIELEWKI
Regulation Number876.5980
Classification Product Code
PIF  
Date Received07/24/2014
Decision Date 11/20/2014
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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