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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 K083765
Device Name MAXGUARD ADVANCED LUER ACTIVATED DEVICE WITH ANTIMICROBIAL
Applicant
MEDEGEN MEDICAL MANUFACTURING SERVICES
930 wanamaker ave.
ontario,  CA  91761
Contact matthew fried
Regulation Number880.5440
Classification Product Code
FPA  
Date Received12/18/2008
Decision Date 12/30/2008
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
statement statement
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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