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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 K072542
Device Name MAXPLUS TRU-SWAB POSITIVE DISPLACEMENT CONNECTOR
Applicant
MEDEGEN MEDICAL MANUFACTURING SYSTEM
930 wannamaker ave.
ontario,  CA  91761
Contact alex mazza
Regulation Number880.5440
Classification Product Code
FPA  
Date Received09/10/2007
Decision Date 09/25/2007
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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