FDA 510(k) Application Details - K020772

Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

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510(K) Number K020772
Device Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Applicant HOWMEDICA OSTEONICS CORP.
59 ROUTE 17 SOUTH
ALLENDALE, NJ 07401-1677 US
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Contact KAREN ARIEMMA
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Regulation Number 888.3030

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Classification Product Code KTT
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Date Received 03/08/2002
Decision Date 06/05/2002
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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