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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 K120903
Device Name CONGRUENT BONE PLATE SYSTEM: ACU-LOC 2 PLATE
Original Applicant
ACUMED LLC
5885 nw cornelius pass rd.
hillsboro,  OR  97124 -9432
Original Contact brittany cunningham
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received03/26/2012
Decision Date 07/13/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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