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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name set, administration, intravascular
510(k) Number K990083
Device Name CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECURIT SHELL, SECURITY SHELL ADAPTER
Original Applicant
SIMS DELTEC, INC.
1265 grey fox rd.
st. paul,  MN  55112
Original Contact edward w numainville
Regulation Number880.5440
Classification Product Code
FPA  
Date Received01/11/1999
Decision Date 02/12/1999
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
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