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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 K000328
Device Name MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMP
Applicant
MEDEX, INC.
6250 SHIER RINGS RD.
DUBLIN,  OH  40316
Applicant Contact CATHY CHENETSKI
Correspondent
MEDEX, INC.
6250 SHIER RINGS RD.
DUBLIN,  OH  40316
Correspondent Contact CATHY CHENETSKI
Regulation Number880.5725
Classification Product Code
FRN  
Date Received02/02/2000
Decision Date 05/09/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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