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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 (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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