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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 St.
Mansfield,  MA  02048
Applicant Contact BRIDGET GARDNER
Correspondent
Tyco Healthcare/Kendall
15 Hampshire St.
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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