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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 K012655
Device Name CONGRUENT BONE PLATE SYSTEM
Original Applicant
ACUMED, INC.
10950 s.w. 5th st.
suite 170
beaverton,  OR  97005
Original Contact shari jeffers
Regulation Number888.3030
Classification Product Code
HRS  
Date Received08/13/2001
Decision Date 11/07/2001
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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