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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mesh, surgical, polymeric
510(k) Number K133889
Device Name PREMIUM
Applicant
COUSIN BIOTECH S.A.S.
8 RUE DE L ABBE BONPAIN
ALLEE DES ROSES
WERVICQ-SUD,  FR 59117
Applicant Contact FRANCK PELLETIER
Correspondent
COUSIN BIOTECH S.A.S.
8 RUE DE L ABBE BONPAIN
ALLEE DES ROSES
WERVICQ-SUD,  FR 59117
Correspondent Contact FRANCK PELLETIER
Regulation Number878.3300
Classification Product Code
FTL  
Date Received12/20/2013
Decision Date 09/04/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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