FDA 510(k) Application Details - K023365

Device Classification Name Screw, Fixation, Bone

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510(K) Number K023365
Device Name Screw, Fixation, Bone
Applicant JEIL MEDICAL CORPORATION
PO BOX 7007
DEERFILED, IL 60015 US
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Contact DANIEL KAMM
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Regulation Number 888.3040

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Classification Product Code HWC
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Date Received 10/07/2002
Decision Date 04/18/2003
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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