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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 K895769
Device Name EXEL HUBER NEEDLE
Original Applicant
EXEL INTL.
p.o. box 3194
culver city,  CA  90231 3194
Original Contact eshagh hamid
Regulation Number880.5570
Classification Product Code
FMI  
Date Received09/26/1989
Decision Date 02/16/1990
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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