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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name syringe, piston
510(k) Number K983974
Device Name OWEN MUMFORD 3ML AUTOPEN
Applicant
Owen Mumford USA, Inc.
849 PICKENS INDUSTRIAL DR.
SUITE 14
MARIETTA,  GA  30062
Applicant Contact ROBERT SHAW
Correspondent
Owen Mumford USA, Inc.
849 PICKENS INDUSTRIAL DR.
SUITE 14
MARIETTA,  GA  30062
Correspondent Contact ROBERT SHAW
Regulation Number880.5860
Classification Product Code
FMF  
Date Received11/09/1998
Decision Date 12/21/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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