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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
510(k) Number K040899
Device Name MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP
Applicant
MEDEX, INC.
6250 SHIER RINGS RD.
DUBLIN,  OH  40316
Applicant Contact BARBARA LAW
Correspondent
MEDEX, INC.
6250 SHIER RINGS RD.
DUBLIN,  OH  40316
Correspondent Contact BARBARA LAW
Regulation Number880.5725
Classification Product Code
FRN  
Date Received04/06/2004
Decision Date 04/30/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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