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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 K914216
Device Name FRENTA II+ ENTERAL FEEDING PUMP
Applicant
Fresenius Pharma
120 Albany St., Suite 700
New Brunswick,  NJ  08903
Applicant Contact RONALD GUIDO
Correspondent
Fresenius Pharma
120 Albany St., Suite 700
New Brunswick,  NJ  08903
Correspondent Contact RONALD GUIDO
Regulation Number880.5725
Classification Product Code
LZH  
Date Received09/19/1991
Decision Date 03/18/1992
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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