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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 K051568
Device Name CADD-MS 3 AMBULATORY INFUSION PUMP
Original Applicant
SMITHS MEDICAL MD, INC.
1265 grey fox rd.
st. paul,  MN  55112
Original Contact melanie hess
Regulation Number880.5725
Classification Product Code
FRN  
Date Received06/14/2005
Decision Date 11/17/2005
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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