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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Tube, Feeding
510(k) Number K895923
Device Name METRICARE ENTERAL FEEDING SYSTEM
Applicant
Metrix Co.
Evergreen Park
Dubuque,  IA  52001
Applicant Contact DONNELLE FUERSTE
Correspondent
Metrix Co.
Evergreen Park
Dubuque,  IA  52001
Correspondent Contact DONNELLE FUERSTE
Regulation Number876.5980
Classification Product Code
FPD  
Date Received10/11/1989
Decision Date 07/19/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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