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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 K982640
Device Name MEDEX 3000 SERIES SYRINGE INFUSION PUMP
Applicant
MEDEX, INC.
3637 LACON RD.
HILLIARD,  OH  43026
Applicant Contact CATHY CHENETSKI
Correspondent
MEDEX, INC.
3637 LACON RD.
HILLIARD,  OH  43026
Correspondent Contact CATHY CHENETSKI
Regulation Number880.5725
Classification Product Code
FRN  
Date Received07/29/1998
Decision Date 04/06/1999
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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