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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 K061285
Device Name SMARTSITE NEEDLE FREE VALVE ADMINISTRATION SETS
Original Applicant
CARDINAL HEALTH, ALARIS PRODUCTS
10221 wateridge circle
san diego,  CA  92121 2772
Original Contact stacy l lewis
Regulation Number880.5440
Classification Product Code
FPA  
Date Received05/08/2006
Decision Date 07/26/2006
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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