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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, hypodermic, single lumen
510(k) Number K963658
Device Name EXEL AVF SINGLE NEEDLE
Applicant
EXEL INTL.
P.O. BOX 3194
CULVER CITY,  CA  90231 -3194
Applicant Contact ARMAND HAMID
Correspondent
EXEL INTL.
P.O. BOX 3194
CULVER CITY,  CA  90231 -3194
Correspondent Contact ARMAND HAMID
Regulation Number880.5570
Classification Product Code
FMI  
Date Received09/03/1996
Decision Date 05/05/1998
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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