FDA 510(k) Application Details - K073579

Device Classification Name Mesh, Surgical, Polymeric

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510(K) Number K073579
Device Name Mesh, Surgical, Polymeric
Applicant FEG TEXTILTECHNIK FORSCHUNGS-UND ENTWICKLUNGSGESEL
BUSINESS & TECHNOLOGY CENTER/
BESSEMER DRIVE
STEVENAGE SG1 2DX GB
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Contact NEIL R ARMSTRONG
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Regulation Number 878.3300

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Classification Product Code FTL
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Date Received 12/20/2007
Decision Date 08/18/2008
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

FDA Source Information for K073579


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