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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pump, infusion, enteral
510(k) Number K954735
Device Name ENTERALITE
Applicant
ZEVEX INTL., INC.
P.O. BOX 414
WEST JORDAN,  UT  80404 -0414
Applicant Contact DAN REIGLE
Correspondent
ZEVEX INTL., INC.
P.O. BOX 414
WEST JORDAN,  UT  80404 -0414
Correspondent Contact DAN REIGLE
Regulation Number880.5725
Classification Product Code
LZH  
Date Received10/16/1995
Decision Date 04/15/1996
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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