FDA 510(k) Application Details - K120019

Device Classification Name Mesh, Surgical

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510(K) Number K120019
Device Name Mesh, Surgical
Applicant WRIGHT MEDICAL TECHNOLOGY, INC.
5677 AIRLINE RD.
ARLINGTON, TN 38002 US
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Contact LESLIE FITCH
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Regulation Number 878.3300

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Classification Product Code FTM
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Date Received 01/03/2012
Decision Date 02/23/2012
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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