FDA 510(k) Application Details - K964458

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

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510(K) Number K964458
Device Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Applicant LINK AMERICA, INC.
3700 SOUTH TAMIAMI TRAIL
SARASOTA, FL 34239 US
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Contact DOUGLAS W STUART
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Regulation Number 888.3030

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Classification Product Code KTT
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Date Received 11/07/1996
Decision Date 12/09/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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