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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 K012147
Device Name DEVICE MODIFICATION OF ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE
Applicant
ZEVEX, INC.
4314 ZEVEX PARK LN.
SALT LAKE CITY,  UT  84123
Applicant Contact SUSAN P SCHMIDT
Correspondent
ZEVEX, INC.
4314 ZEVEX PARK LN.
SALT LAKE CITY,  UT  84123
Correspondent Contact SUSAN P SCHMIDT
Regulation Number876.5980
Classification Product Code
KNT  
Date Received07/10/2001
Decision Date 11/02/2001
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
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