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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 K060041
Device Name TRIMED BONE PLATES
Applicant
TRIMED, INC.
25864 TOURNAMENT RD. SUITE A
VALENCIA,  CA  91355
Applicant Contact KELLI ANDERSON
Correspondent
TRIMED, INC.
25864 TOURNAMENT RD. SUITE A
VALENCIA,  CA  91355
Correspondent Contact KELLI ANDERSON
Regulation Number888.3030
Classification Product Code
HRS  
Date Received01/06/2006
Decision Date 02/07/2006
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
Recalls CDRH Recalls
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