FDA 510(k) Application Details - K960219

Device Classification Name Mesh, Surgical, Polymeric

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510(K) Number K960219
Device Name Mesh, Surgical, Polymeric
Applicant ADVANCED SURGICAL INNOVATIONS, INC.
6890 PACIFIC CIRCLE
MISSISSAUGA, ONTARIO L5TIN8 CA
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Contact DAVID M OLSEN
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Regulation Number 878.3300

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Classification Product Code FTL
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Date Received 01/16/1996
Decision Date 03/15/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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