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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 K111266
Device Name EASYLOCK OSTEOSYSTEM
Original Applicant
TRIMED, INC.
27533 avenue hopkins
santa clarita,  CA  91355
Original Contact doug steinberger
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received05/04/2011
Decision Date 10/06/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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