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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 K031199
Device Name ENTERALITE INFINITY ENTERAL FEEDING PUMP
Applicant
ZEVEX INTL., INC.
16787 BERNARDO CENTER DR.
SUITE A-1
SAN DIEGO,  CA  92128
Applicant Contact SEAN M CURRY
Correspondent
ZEVEX INTL., INC.
16787 BERNARDO CENTER DR.
SUITE A-1
SAN DIEGO,  CA  92128
Correspondent Contact SEAN M CURRY
Regulation Number880.5725
Classification Product Code
LZH  
Date Received04/14/2003
Decision Date 07/09/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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