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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
510(k) Number K820063
Device Name KEOFEED 500 ENTERIC FEEDING PUMP
Applicant
Hedeco
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Hedeco
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.5725
Classification Product Code
FRN  
Date Received01/11/1982
Decision Date 02/10/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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