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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 K100123
Device Name ACUMED WRIST ARTHRODESIS PLATE SYSTEM
Original Applicant
ACUMED LLC
5885 nw cornelius pass rd.
hillsboro,  OR  97124 9432
Original Contact lino tsai
Regulation Number888.3030
Classification Product Code
HRS  
Date Received01/15/2010
Decision Date 10/06/2010
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
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