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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 K093196
Device Name BIOMESH CA.B.S. 'AIR COMPOSITE, MODELS: CABST1R05T, CABSAIRC7, CABSAIRC09
Applicant
COUSIN BIOTECH S.A.S.
8 RUE DE L'ABBE BONPAIN
WERVICQ-SUD,  FR 59117
Applicant Contact FRANCK PELLETIER
Correspondent
COUSIN BIOTECH S.A.S.
8 RUE DE L'ABBE BONPAIN
WERVICQ-SUD,  FR 59117
Correspondent Contact FRANCK PELLETIER
Regulation Number878.3300
Classification Product Code
FTL  
Subsequent Product Code
OQL  
Date Received10/09/2009
Decision Date 06/25/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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