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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 K112636
Model 456081, 456082
Device Name CYTOGUARD(TM) CLOSED LUER CONNECTOR
Original Applicant
B. BRAUN MEDICAL, INC.
901 marcon blvd.
allentown,  PA  18109 9341
Original Contact angela j caravella
Regulation Number880.5440
Classification Product Code
FPA  
Date Received09/09/2011
Decision Date 11/26/2011
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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