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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, I.V. Fluid Transfer
510(k) Number K895922
Device Name METRICARE EMPTY CONTAINER SYSTEMS
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 Number880.5440
Classification Product Code
LHI  
Date Received10/11/1989
Decision Date 08/22/1990
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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