FDA 510(k) Application Details - K982532

Device Classification Name Mesh, Surgical, Polymeric

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510(K) Number K982532
Device Name Mesh, Surgical, Polymeric
Applicant COGENT
555 THIRTEENTH ST. N.W.
WASHINGTON, DC 20004 US
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Contact HOWARD M HOLSTEIN
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Regulation Number 878.3300

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Classification Product Code FTL
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Date Received 07/20/1998
Decision Date 01/20/1999
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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