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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 K021321
Device Name WRIST FUSION PLATE
Original Applicant
ACUMED, INC.
5885 nw cornelius pass rd.
hillsboro,  OR  97124 9432
Original Contact carrie mcmichael
Regulation Number888.3030
Classification Product Code
HRS  
Date Received04/25/2002
Decision Date 07/17/2002
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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