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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 K150091
Device Name Versatex Monofilament Mesh
Applicant
SOFRADIM PRODUCTION
116 AVENUE DU FORMANS
TREVOUX,  FR 01600
Applicant Contact Benjamin Rochette
Correspondent
COVIDIEN(Surgical Solutions)
60 Middletown Avenue
North Haven,  CT  06473
Correspondent Contact Mary Mellows
Regulation Number878.3300
Classification Product Code
FTL  
Date Received01/16/2015
Decision Date 05/26/2015
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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