FDA 510(k) Application Details - K031969

Device Classification Name Mesh, Surgical

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510(K) Number K031969
Device Name Mesh, Surgical
Applicant DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DRIVE
WARSAW, IN 46581-0988 US
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Contact KATHY K TRIER
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Regulation Number 878.3300

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Classification Product Code FTM
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Date Received 06/26/2003
Decision Date 07/28/2003
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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