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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
Recalls CDRH Recalls
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