FDA 510(k) Application Details - K133889

Device Classification Name Mesh, Surgical, Polymeric

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510(K) Number K133889
Device Name Mesh, Surgical, Polymeric
Applicant COUSIN BIOTECH S.A.S.
8 RUE DE L ABBE BONPAIN
ALLEE DES ROSES
WERVICQ-SUD 59117 FR
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Contact FRANCK PELLETIER
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Regulation Number 878.3300

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Classification Product Code FTL
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Date Received 12/20/2013
Decision Date 09/04/2014
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

FDA Source Information for K133889


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