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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 K121554
Device Name Q-FLO CLOSED MALE LUER CONNECTOR
Applicant
INFUSION INNOVATIONS, INC.
7514 girard avenue
lajolla,  CA  92037
Contact babak nemati
Regulation Number880.5440
Classification Product Code
FPA  
Date Received05/25/2012
Decision Date 06/08/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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