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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 K111386
Model 4000, 2, SERIES 2
Device Name MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS)
Original Applicant
SMITHS MEDICAL MD, INC.
1265 grey fox rd.
st. paul,  MN  55112
Original Contact james chapman
Regulation Number880.5725
Classification Product Code
FRN  
Subsequent Product Code
MRZ  
Date Received05/18/2011
Decision Date 08/29/2011
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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