FDA 510(k) Application Details - K220540

Device Classification Name Mesh, Surgical, Polymeric

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510(K) Number K220540
Device Name Mesh, Surgical, Polymeric
Applicant Covidien
15 Hampshire Street
Mansfield, MA 02048 US
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Contact Jonas Gulmez
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Regulation Number 878.3300

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Classification Product Code FTL
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Date Received 02/25/2022
Decision Date 09/22/2022
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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