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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, I.V.
510(k) Number K895924
Device Name METRICARE DRUG RESERVOIRS
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 Number880.5025
Classification Product Code
KPE  
Date Received10/11/1989
Decision Date 07/26/1990
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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