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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 K192443
Device Name Dextile Anatomical Mesh
Sofradim Production
116 avenue du Formans
Trevoux,  FR 01600
Applicant Contact Benjamin Rochette
60 Middletown Avenue
North Haven,  CT  06473
Correspondent Contact Angela Van Arsdale
Regulation Number878.3300
Classification Product Code
Date Received09/06/2019
Decision Date 12/06/2019
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