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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 K030888
Device Name EVA EMPTY SOLUTION CONTAINER
Applicant
METRIX CO.
4400 CHAVENELLE RD.
DUBUQUE,  IA  52002
Applicant Contact JAMES J OLDHAM
Correspondent
METRIX CO.
4400 CHAVENELLE RD.
DUBUQUE,  IA  52002
Correspondent Contact JAMES J OLDHAM
Regulation Number880.5025
Classification Product Code
KPE  
Date Received03/21/2003
Decision Date 04/02/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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