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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 (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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