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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 K040636
Device Name CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION CASSETTE RESERVOIR WITH FLOW STOP AND EXTENSION SET
Original Applicant
SMITHS MEDICAL MD, INC.
1265 grey fox rd.
st. paul,  MN  55112
Original Contact patricia a laforte
Regulation Number880.5440
Classification Product Code
FPA  
Date Received03/10/2004
Decision Date 05/19/2004
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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