FDA 510(k) Application Details - K033856

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

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510(K) Number K033856
Device Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Applicant PETER STEVENS, MD
PO BOX 58246
SALT LAKE CITY, UT 84158 US
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Contact PETER STEVENS, MD
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Regulation Number 888.3030

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Classification Product Code KTT
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Date Received 12/11/2003
Decision Date 01/07/2005
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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