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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 K960280
Device Name IVAC NEEDLE FREE VALVE ADMINISTRATION SETS
Original Applicant
Y
10300 campus point dr.
san diego,  CA  92121 1579
Original Contact jennifer s hankard
Regulation Number880.5440
Classification Product Code
FPA  
Date Received01/19/1996
Decision Date 04/04/1996
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
Recalls CDRH Recalls
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