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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
Applicant Contact DAN REIGLE
Correspondent
Zevex Intl., Inc.
P.O. Box 414
West Jordan,  UT  80404
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
Predetermined Change
Control Plan Authorized		 No
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