FDA 510(k) Application Details - K102215

Device Classification Name Pin, Fixation, Smooth

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510(K) Number K102215
Device Name Pin, Fixation, Smooth
Applicant EVERGREEN ORTHOPEDIC RESEARCH LAB
11321 NE 120TH ST
KIRKLAND, WA 98034 US
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Contact WAYNE MORSE
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Regulation Number 888.3040

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Classification Product Code HTY
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Date Received 08/06/2010
Decision Date 11/09/2010
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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