FDA 510(k) Application Details - K230227

Device Classification Name Mesh, Surgical, Polymeric

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510(K) Number K230227
Device Name Mesh, Surgical, Polymeric
Applicant Deep Blue Medical Advances, Inc.
701 W Main Street, Suite 410
Durham, NC 27701 US
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Contact William Perry
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Regulation Number 878.3300

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Classification Product Code FTL
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Date Received 01/27/2023
Decision Date 02/23/2023
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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