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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 K042172
Device Name CLEO 90 INFUSION SET
Original Applicant
SMITHS MEDICAL MD, INC.
1265 grey fox road
st. paul,  MN  55112
Original Contact david h short
Regulation Number880.5440
Classification Product Code
FPA  
Date Received08/11/2004
Decision Date 10/07/2004
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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