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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
Applicant Contact ALEX MAZZA
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 Received09/10/2007
Decision Date 09/25/2007
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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