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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 K955231
Device Name MEDFUSION MODEL 2001 SYRINGE INFUSION PUMP
Applicant
MEDEX, INC.
11360 TECHNOLOGY CIR.
DULUTH,  GA  30155
Applicant Contact J H RUFFIN BOOTH
Correspondent
MEDEX, INC.
11360 TECHNOLOGY CIR.
DULUTH,  GA  30155
Correspondent Contact J H RUFFIN BOOTH
Regulation Number880.5725
Classification Product Code
FRN  
Date Received11/14/1995
Decision Date 07/18/1996
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
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