FDA 510(k) Application Details - K182087

Device Classification Name Mesh, Surgical, Polymeric

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510(K) Number K182087
Device Name Mesh, Surgical, Polymeric
Applicant FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft
mbH
Prager Ring 70
Aachen D-52070 DE
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Contact Stefan Schneemelcher
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Regulation Number 878.3300

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Classification Product Code FTL
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Date Received 08/02/2018
Decision Date 10/31/2018
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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