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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K040112
Device Name TRIMED BEARING PLATE; TRIMED VOLAR BEARING PLATE
Applicant
Tri-Med, Inc.
25768 Parada Dr.
Valencia,  CA  91355
Applicant Contact ROBERT J MEDOFF
Correspondent
Tri-Med, Inc.
25768 Parada Dr.
Valencia,  CA  91355
Correspondent Contact ROBERT J MEDOFF
Regulation Number888.3030
Classification Product Code
HRS  
Date Received01/20/2004
Decision Date 03/12/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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