FDA 510(k) Application Details - K023882

Device Classification Name Mesh, Metal

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510(K) Number K023882
Device Name Mesh, Metal
Applicant IMPLEX CORP.
80 COMMERCE DR.
ALLENDALE, NJ 07401-1600 US
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Contact ROBERT POGGIE
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Regulation Number 878.3300

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Classification Product Code EZX
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Date Received 11/21/2002
Decision Date 02/19/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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