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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 K030881
Device Name AVANTA CARPAL FUSION PLATING SYSTEM
Original Applicant
AVANTA ORTHOPAEDICS, INC.
8600 evergreen blvd.
minneapolis,  MN  55433
Original Contact h. doug plunkett
Regulation Number888.3030
Classification Product Code
HRS  
Date Received03/20/2003
Decision Date 04/10/2003
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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