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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 K112509
Device Name TRIMED CLAVICLE FIXATION SYSTEM
Applicant
TriMed, Inc.
27533 Ave. Hopkins
Valencia,  CA  91355
Applicant Contact DOUG STEINBERGER
Correspondent
TriMed, Inc.
27533 Ave. Hopkins
Valencia,  CA  91355
Correspondent Contact DOUG STEINBERGER
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received08/30/2011
Decision Date 11/04/2011
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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