FDA 510(k) Application Details - K030881

Device Classification Name Plate, Fixation, Bone

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510(K) Number K030881
Device Name Plate, Fixation, Bone
Applicant AVANTA ORTHOPAEDICS, INC.
8600 EVERGREEN BLVD.
MINNEAPOLIS, MN 55433 US
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Contact H. DOUG PLUNKETT
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Regulation Number 888.3030

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Classification Product Code HRS
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Date Received 03/20/2003
Decision Date 04/10/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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