FDA 510(k) Application Details - K023360

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

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510(K) Number K023360
Device Name Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
Applicant JEIL MEDICAL CORPORATION
PO BOX 7007
DEERFILED, IL 60015 US
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Contact DANIEL KAMM
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Regulation Number 888.3030

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Classification Product Code KTW
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Date Received 10/07/2002
Decision Date 10/25/2002
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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