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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name introducer, syringe needle
510(K) Number K122837
Model AJ-1395
Device Name AUTOJECT 2 FOR GLASSY SYRINGE
Applicant
OWEN MUMFORD, LTD.
brook hill
woodstock, oxfordshire, 
Contact darren mansell
Regulation Number880.6920
Classification Product Code
KZH  
Date Received09/17/2012
Decision Date 10/15/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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