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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
Applicant Contact MATTHEW FRIED
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number880.5440
Classification Product Code
FPA  
Date Received12/18/2008
Decision Date 12/30/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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