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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 K000482
Device Name MODIFICATION TO AUTOJECT MINI
Applicant
Owen Mumford, Ltd.
849 Pickens Industrial Dr.
Suite 14
Marietta,  GA  30062
Applicant Contact ROBERT SHAW
Correspondent
Owen Mumford, Ltd.
849 Pickens Industrial Dr.
Suite 14
Marietta,  GA  30062
Correspondent Contact ROBERT SHAW
Regulation Number880.6920
Classification Product Code
KZH  
Date Received02/14/2000
Decision Date 03/06/2000
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
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