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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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