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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 K040196
Device Name KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETS
Applicant
TYCO HEALTHCARE/KENDALL
15 HAMPSHIRE STREET
MANSFIELD,  MA  02048
Applicant Contact BRIDGET GARDNER
Correspondent
TYCO HEALTHCARE/KENDALL
15 HAMPSHIRE STREET
MANSFIELD,  MA  02048
Correspondent Contact BRIDGET GARDNER
Regulation Number880.5725
Classification Product Code
LZH  
Date Received01/29/2004
Decision Date 05/05/2004
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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