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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 K012879
Device Name EXEL HUBER INFUSION SET WITH NEEDLELESS INJECTION SITE
Applicant
EXELINT INTL. CO.
5840 WEST CENTINELA AVE.
LOS ANGELES,  CA  90045
Applicant Contact ARMAND HAMID
Correspondent
EXELINT INTL. CO.
5840 WEST CENTINELA AVE.
LOS ANGELES,  CA  90045
Correspondent Contact ARMAND HAMID
Regulation Number880.5440
Classification Product Code
FPA  
Date Received08/28/2001
Decision Date 01/17/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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