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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 K945660
Device Name AUTOJECT 2
Applicant
OWEN MUMFORD USA, INC.
849 PICKENS INDUSTRIAL DR.
SUITE 14
MARIETTA,  GA  30062
Applicant Contact ROBERT E SHAW
Correspondent
OWEN MUMFORD USA, INC.
849 PICKENS INDUSTRIAL DR.
SUITE 14
MARIETTA,  GA  30062
Correspondent Contact ROBERT E SHAW
Regulation Number880.6920
Classification Product Code
KZH  
Date Received11/17/1994
Decision Date 08/11/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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