FDA 510(k) Application Details - K120025

Device Classification Name Mesh, Surgical, Polymeric

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510(K) Number K120025
Device Name Mesh, Surgical, Polymeric
Applicant ASPIDE MEDICAL
555 THIRTEENTH ST. NW
COLUMBIA SQUARE
WASHINGTON, DC 20004-1109 US
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Contact JOHN J SMITH
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Regulation Number 878.3300

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Classification Product Code FTL
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Date Received 01/03/2012
Decision Date 06/26/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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