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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 K062592
Device Name CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE
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 Received09/01/2006
Decision Date 11/29/2006
Decision substantially equivalent (SESE)
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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