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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 K041179
Device Name MODIFICATION TO THE NAC PLUS NEEDLELESS ACCESS CONNECTOR
Applicant
MEDEGEN MEDICAL MANUFACTURING SERVICES, INC.
930 WANAMAKER
ONTARIO,  CA  91761 -8151
Applicant Contact TIM TRUITT
Correspondent
MEDEGEN MEDICAL MANUFACTURING SERVICES, INC.
930 WANAMAKER
ONTARIO,  CA  91761 -8151
Correspondent Contact TIM TRUITT
Regulation Number880.5440
Classification Product Code
FPA  
Date Received05/06/2004
Decision Date 06/04/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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