FDA 510(k) Application Details - K072370

Device Classification Name Mesh, Surgical, Polymeric

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510(K) Number K072370
Device Name Mesh, Surgical, Polymeric
Applicant SURGICRAFT LTD.
111 HILL ROAD
DOUGLASSVILLE, PA 19518 US
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Contact DONALD GUTHNER
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Regulation Number 878.3300

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Classification Product Code FTL
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Date Received 08/23/2007
Decision Date 07/24/2008
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



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