FDA 510(k) Application Details - K973231

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

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510(K) Number K973231
Device Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Applicant CORIN U.S.A.
10500 UNIVERSITY CENTER DR.,
SUITE 190
TAMPA, FL 33612 US
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Contact CRAIG CORRANCE
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Regulation Number 888.3030

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Classification Product Code KTT
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Date Received 08/27/1997
Decision Date 11/20/1997
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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