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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 K172395
Device Name Duatene bilayer mesh
Sofradim Production
116 avenue du Formans
Trevoux,  FR 01600
Applicant Contact Benjamin Rochette
60 Middletown Avenue
North Haven,  CT  06473
Correspondent Contact Jose Marquez
Regulation Number878.3300
Classification Product Code
Date Received08/08/2017
Decision Date 02/01/2018
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