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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
Device Name AUTOJECT 2 FOR GLASSY SYRINGE
Applicant
Owen Mumford, Ltd.
Brook Hill
Woodstock, Oxfordshire,  GB 0X20ITU
Applicant Contact DARREN MANSELL
Correspondent
Owen Mumford, Ltd.
Brook Hill
Woodstock, Oxfordshire,  GB 0X20ITU
Correspondent Contact DARREN MANSELL
Regulation Number880.6920
Classification Product Code
KZH  
Date Received09/17/2012
Decision Date 10/15/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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